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BREAST CANCER CASE STUDY

Oct 01, 2014

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BREAST CANCER CASE STUDY. FRAZER BELL STUDENT BMS BSc APPLIED BIOMEDICAL SCIENCE. PATIENT HISTORY. 70 YEAR OLD FEMALE PRESENTED AT GP SURGERY 02/OCT/2012 EXAMINATION: RIGHT NIPPLE DRAWING IN & FIRM PALPABLE LUMP REFERRED TO THE BREAST CLINIC. BREAST CLINIC. ATTENDED 18/OCT/2012

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• receptor status
• oestrogen receptor
• staging investigations
• oestrogen receptor status
• sentinel lymph node biopsy

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BREAST CANCERCASE STUDY FRAZER BELL STUDENT BMS BSc APPLIED BIOMEDICAL SCIENCE

PATIENT HISTORY • 70 YEAR OLD FEMALE • PRESENTED AT GP SURGERY 02/OCT/2012 • EXAMINATION: RIGHT NIPPLE DRAWING IN & FIRM PALPABLE LUMP • REFERRED TO THE BREAST CLINIC

BREAST CLINIC • ATTENDED 18/OCT/2012 • EXAMINATION: INVERTED NIPPLE RETRACTION AND PALPABLE LUMP • ? PALPABLE LUMP RIGHT AXILLA • GRADED P5: MALIGNANT • FURTHER INVESTIGATIONS: MAMMOGRAM, ULTRASOUND & BREAST CORE BIOPSY

MAMMOGRAPHY • AREA OF SUSPICIOUS ABNORMALITY ON RIGHT BREAST • GRADED M4: PROBABLY MALIGNANT

ULTRASOUND • ULTRASOUND : CORRESPONDING 2CM AREA • GRADED U4: PROBABLY MALIGNANT

BIOPSY • ULTRASOUND GUIDED BREAST CORE BIOPSIES FROM THE RIGHT BREAST • ONE 13MM FIBROFATTY CORE PLUS 4 FIBROFATTY FRAGMENTS

NORMAL BREAST TISSUE

PATHOLOGY GRADED: B5b Infiltrating Breast Carcinoma

IMMUNOCYTOCHEMISTRY E-CAD NEGATIVE

RECEPTOR STATUS • OESTROGEN RECEPTOR & HER-2 STATUS • DETERMINE RECEPTOR STATUS FOR HORMONE THERAPY

OESTROGEN RECEPTOR STATUS NEGATIVE CONTROL OESTROGEN POSITIVE

PROGESTERONE REC. STATUS PROG POSITIVE NEGATIVE CONTROL

HER-2 STATUS HER2 NEGATIVE NEGATIVE CONTROL

TREATMENT PLAN • BREAST MDT MEETING • MASTECTOMY WITHOUT NEOADJUVANT TREATMENT • SENTINEL LYMPH NODE BIOPSY • SURGERY DATE 06/NOV/2012

PRE-OP ASSESSMENT • ADMITTED PRE-OP CLINIC 01/NOV/2012 • LABS TESTS: PRE-OP BLOODS • HYPERTENSIVE • MEDICAL WARD: ECG CONFIRMED LVH • SURGERY CANCELLED

TREATMENT PLAN • REDUCE BLOOD PRESSURE VIA ACE INHIBITORS • CHEST X-RAY & U/S OF KIDNEYS • STARTED ON LETROZOLE 2.5mg DAILY • BP MONITORED FORTNIGHTLY • RE-ASSESSMENT FOR SURGERY IN JANUARY

SURGERY • BP STABILISED • ADMITTED TO SURGICAL WARD 13/FEB/13 • SURGERY 25/FEB/13 • RIGHT BREAST MASTECTOMY • SENTINEL LYMPH NODE BIOPSY

MASTECTOMY • 19MM AND 7MM FIRM NODULES UPON DISSECTION • NO LYMPHOVASCULAR INVASION • 12MM CLEARANCE DEEP MARGIN

HISTOPATHOLOGY TUMOUR GRADE 2 INVASIVE LOBULAR CARCINOMA

SENTINEL LYMPH NODE • FIVE SENTINEL NODES • FOUR NEGATIVE • ONE POSITIVE DEPOSIT OF METASTATIC TUMOUR • ICC: AE1/AE3 CYTOKERATIN

SENTINEL LYMPH NODE AE1/AE3 POSITIVE H&E SENTINEL NODE

POST-OPERATIVE • GRADE 2 INVASIVE LOBULAR CARCINOMA • CLOSEST RELEVANT MARGIN 12MM • SINGLE NODE POSITIVITY • STAGING INVESTIGATIONS REQUIRED

STAGING INVESTIGATIONS • STAGING INVESTIGATIONS TO EXCLUDE METASTASES • CT SCAN - NEGATIVE • BONE SCAN - NEGATIVE

FUTURE • PATIENT DECLINED CHEMOTHERAPY • WILL ATTEND THE BEATSON CANCER CENTRE • RADIOTHERAPY TREATMENT • CONTINUE LETROZOLE

ACKNOWLEDGEMENTS • CONS. PATHOLOGIST Dr. A. W. Milne • CROSSHOUSE PATHOLOGY DEPT.

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Patient Case Presentation

Patient Mrs. B.C. is a 56 year old female who is presenting to her WHNP for her annual exam. She had to cancel her appointment two months ago and didn’t reschedule until now. Her last pap smear and mammogram were normal. Today, while performing her breast exam, her nurse practitioner notices dimpling in the left breast as the patient raises her arms over her head. When the NP mentions it to Mrs. B.C. she is surprised and denies noticing it before today. A firm, non-tender, immobile nodule is palpated in the upper quadrant of her breast . The NP then asks Mrs. B.C. how frequently she is performing breast self-exams, she admits to only doing them randomly when she remembers, which is about every few months. She reports no recent or abnormal drainage from her breast. Further examination reveals palpable axillary lymph nodes. 

Mrs. B.C. is about 30 pounds overweight and walks her dog around her neighborhood every morning before work and every evening when she gets home. She reports drinking a glass of white wine before bed each night. She denies any history of tobacco use. She reports use of a combination birth control pill on and off for 25 years until she reached menopause. She is not currently taking any prescription medications. 

Past Medical History

• Menarche (Age 10)
• Post-menopausal (Age 53)
• No other pertinent medical history

Family History:

• Father George- deceased from stroke (75 years old), history of hypertension, CAD, HLD
• Mother Maryanne alive- 76 years old, history of dementia, osteoporosis 
• Brother Michael- alive, 57 years old, history of hypertension, CAD and cardiac stent placement (54 years old)
• Sister, Michelle- alive 53 years old, history of GERD, Asthma
• Brother- Jimmy- alive 50 years old, no past medical history

Social History: 

Mrs. B.C. works Monday-Friday 8am-5pm at the local dentist’s office at the front desk as a schedule coordinator. She is planning to retire in a few years. In her spare time, she is involved in various community efforts to feed the homeless and helps to prepare dinners at her local church one night a week. She also enjoys cooking and baking at home, gardening, and nature photography. 

Mrs. B.C. has two children. Her oldest son, Patrick, is 21 years old and is in his final year of pre-med. He is attending a public university about 2 hours away from home where he lives year-round. As an infant, Patrick was breastfed until 18 months when he self-weaned. Her daughter, Veronica, is 19 years old and lives at home while attending the local branch campus of a state university. She is in her second year of a business degree and then plans to transfer to the main campus next year. When Veronica was an infant she had difficulty latching onto the breast due to an undiagnosed tongue and lip ties resulting in Mrs. BC exclusively pumping and bottle feeding for six months. After six months, Mrs. B.C. was having a hard time keeping up while working and her found her supply diminished. Veronica had begun eating solid foods so Mrs. B.C. switched to supplemental formula, which was a big relief.

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• Understanding Breast Cancer
• Slide Show - Slide Show

*This slide show represents a visual interpretation and is not intended to provide, nor substitute as, medical and/or clinical advice.

Breasts are made up of fatty tissue. They contain small chambers called lobules where breast milk is made. The milk travels through tiny channels called ducts to reach the nipples.

Lymph nodes are located inside your breasts and under your arms. They are connected by lymph vessels and they help your body fight disease.

Breast cancer occurs when healthy breast cells become abnormal, grow out of control, and form tumors. Breast cancer can sometimes spread to other parts of the body.

About 1 in 8 women have a lifetime risk of getting breast cancer. For men, the risk is 1 in 1,000.

Breast cancer that develops inside the milk ducts is called “ ductal carcinoma in situ ", or DCIS . When DCIS spreads into surrounding tissue, it is called “ invasive ductal carcinoma ”, or IDC .

Abnormal cells can develop in the lobules of the breast. They are called “ lobular carcinoma in situ ", or LCIS , and are not cancer. When these cells spread into surrounding tissue, they become a cancer called “ invasive lobular carcinoma ”.

Signs of breast cancer can include:

• A lump in the breast or armpit;
• A change in breast shape or size;
• Nipple changes or discharge; and
• Skin changes, including redness, inflammation or dimpling like the skin of an orange.

Risk factors for breast cancer include:

• Dense breasts,
• Having breast cancer before, or having a parent or sibling who had it,
• Having specific, inherited gene mutations called BRCA1 and BRCA2
• Having Ashkenazi Jewish ancestry;
• Drinking more than a small amount of alcohol, and
• Being overweight or obese, especially after menopause.

Screening for breast cancer can help find cancer early and save lives.

Screening includes:

• Examining your own breasts;
• Having a healthcare provider examine them; and
• Having an X-ray of the breasts called a screening mammogram.

You can check your own breasts about the same time each month. Feel each breast and armpit and look for any of the signs of breast cancer previously discussed.

A diagnostic mammogram is used when a change is seen on a screening mammogram. It includes extra detailed images of the breast.

A breast ultrasound is often used to determine if a suspicious lump is solid or fluid-filled. A fluid-filled lump is often benign or a cyst, while a solid lump can be cancerous or a benign fibrous growth.

A breast MRI shows more detail than a mammogram, and is often used for very small masses or changes in the breast that cannot be seen by mammogram.

A breast biopsy is a test that removes a few cells or a small amount of tissue from the suspicious area in the breast. There are various types of biopsies.

A doctor called a pathologist will analyze the breast biopsy tissue by looking at the cells under a microscope and doing specific tests. Their report will let you know if you have cancer and if it grew because of estrogen, progesterone or HER2/neu protein on the cancer cell.

The results of these tests help your doctor choose the right treatment.

Doctors classify breast cancers based on how they behave. This includes:

• Non-invasive – cancer that has not spread outside the tissue where it began,
• Invasive – cancer that has spread and invaded healthy tissue,
• Recurrent – cancer that returns after it was treated, and
• Metastatic – cancer that has spread from the area where it started to other areas of the body .

Common types of breast cancer are:

• Invasive ductal carcinoma, and
• Invasive lobular cancer.

Less common types of breast cancer include:

• Inflammatory breast cancer,
• Tubular breast cancer,
• Colloid breast cancer, and
• Metaplastic breast cancer.

Triple-negative breast cancer means the tumor has no estrogen, progesterone, or HER2/neu protein receptors on its surface. Triple negative disease may have a worse outcome and often requires more intensive treatment.

Breast cancer staging is determined by the size and location of the cancer and whether it has spread to other areas in your body.

Breast cancers are graded 1 through 3, with 1 being the most similar to normal, healthy cells and 3 being the most different from normal cells and the most aggressive.

Breast cancer treatment depends on the type and stage of your cancer. You will need treatment from a cancer team specializing in different areas of medicine.

The main treatments include surgery , radiation , chemotherapy , hormone therapy , targeted therapy , and combination treatments .

Common types of surgery for breast cancer are:

• Lumpectomy (removing the tumor and a small portion of healthy normal tissue around it);
• Simple mastectomy (removing the entire breast);
• Modified radical mastectomy (removing the entire breast and lymph nodes under the arm);
• Prophylactic mastectomy (removing one or both breasts to reduce the risk of developing breast cancer);
• Mastectomy with reconstruction (reconstruction at the same time as removal of the breast);
• Sentinel lymph node biopsy (procedure to determine if one or more lymph nodes contain cancer cells); and
• Axillary node dissection (surgery to remove lymph nodes in the armpit region).

Reconstructive surgery is a procedure done to restore the appearance of the breast after a mastectomy or large tumor removal.

Radiation therapy uses radiation energy to kill cancer cells. It is mostly recommended after surgery or chemotherapy.

Chemotherapy is the use of drugs to destroy cancer cells. Chemotherapy for breast cancer is given as an IV or a pill.

Chemotherapy can be used to:

• Shrink a tumor before surgery (called neoadjuvant chemotherapy );
• Kill cancer cells after surgery (called adjuvant therapy ); and
• Control metastatic breast cancer (called palliative chemotherapy ).

Hormone therapy is given if your tumor is positive for the hormones estrogen or progesterone.

Hormone therapy is used to:

• Lower the risk of breast cancer coming back; and
• Help shrink or slow the growth of metastatic estrogen-receptor-positive breast cancers.

Tamoxifen and aromatase inhibitors are common hormone therapies for breast cancer.

Targeted therapy uses drugs or other substances to identify and fight specific types of cancer cells with less harm to normal cells.

Targeted therapies:

• Stop cancer cells from growing;
• Identify and kill cancer cells; and
• Increase the immune system’s attack on cancer cells.

HER2 is a common protein that is blocked with targeted therapy, for example trastuzumab .

Targeted therapy is often given along with chemotherapy .

Metastatic breast cancer is cancer that has spread from the breast to other areas of the body. The most common places are the liver, bones, lungs, and brain. There is no cure for metastatic breast cancer and treatment is to prolong survival.

Today , people are living 5 , 10 , or more years with metastatic breast cancer due to advances in treatment.

Metastatic breast cancer treatment may include ongoing chemotherapy, hormone therapy, targeted therapy, and new innovative medicines in clinical trials, such as immunotherapy.

Survivorship is a term used to describe any one who has had breast cancer and is still living.

As a survivor, you will have different care needs than when you were in treatment. Your cancer team and primary care doctor can help you meet these needs in the years after treatment.

It is frightening to learn you have breast cancer. However, the information available can help you receive timely, individualized, effective treatment that can give you the best chance of being cured.

Ask your doctor or cancer team if you have any questions about your treatment plan.

Slide Show - Understanding Breast Cancer

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Other Modules:

Understanding Breast Cancer - Screening and Diagnosis

Understanding Breast Cancer - Treatment

Understanding Metastatic Breast Cancer

Living Well with Metastatic Breast Cancer

Patient Stories:

Felicia's Story

Nicole's Story

Ruth's Story

This educational activity has been developed by American Breast Cancer Foundation and Mechanisms in Medicine Inc.

This activity is supported by an independent educational grant from Pfizer and Genentech.

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Case Presentation on Locally Advanced breast Cancer

Related Papers

European Respiratory Journal

Annelies Rappaport

International Journal of Women's Health

Nicole Sandhu

Although much emphasis has been placed on the primary presentations of breast cancer, little focus has been placed on how systemic illnesses may affect the breast. In this article, we discuss systemic illnesses that can manifest in the breast. We summarize the clinical features, imaging, histopathology, and treatment recommendations for endocrine, vascular, systemic inflammatory, infectious, and hematologic diseases, as well as for the extramammary malignancies that can present in the breast. Despite the rarity of these manifestations of systemic disease, knowledge of these conditions is critical to the appropriate evaluation and treatment of patients presenting with breast symptoms.

Diagnostic Histopathology

Sarah Pinder

IOSR Journals

Background: Benign breast ds (BBD) are common disease affecting woman mainly. These can be diagnosed by triple assessment including clinical examination, radiological imagings, and a pathological examination. Majority of the benign lesions are not associated with an increased risk for subsequent breast cancer but some may have increased risk of malignancy like atypical hyperplasia. The main problem from women’s patient of view is fear that such a lump may be a cancer. Unlike breast cancer, benign breast diseases have often been difficult to understand, in part due to variety of names that have been used to describe the various conditions. So that clinician requires in-depth knowledge to give clear explanation about breast diseases. Making an early diagnosis and planning the treatment during initial consultations, helps in alleviating unnecessary anxiety about breast cancer and unnecessary long term follow up can be avoided. So, the need for study is to analyze the spectrum of benign breast disease. Method: A total 85 patients diagnosing as benign breast diseases under the inclusion criteria were studied during the period of Oct 2014 to March 2016; in the Dept of Surgery at People’s hospital of People’s college of medical science and research center, Bhopal. Our study objectives were A. To describe the spectrum of Benign Breast Diseases with Respect to Age of incidence, Social Demography, Duration of Symptoms, Site of lumps, Clinical features specific to conditions. B. To diagnose clinically and cytologically (FNAC) Suitable patients with benign breast disease and provide either conservative or operative treatment. C. To do histopathological examination of excised specimen for the comparisons and confirmation of cytological and clinical diagnosis. Result: Fibro adenoma was the most common benign lesion encountered (65.9%) followed by Breast Abscess 18.8% disease. Fibro adenoma was presented most often in the second and third decade (75%). Lump in the breast was the commonest presentation of BBD, Lump and Mastalgia was the second commonest symptom of BBD. There was a slight preponderance of lesions in the right breast (45.9%) as compared to left breast (44.7%), shown to be significant. Most of patients belong to middle class. 100% 0f the patients were in pre menopausal group. Majority (45.9%) of lesions were of the size 2-5 cms, 31.8% were between 6-10 cms FNAC highly reliable for fibro adenoma than for other lesions. All fibro adenomas willing for surgical procedure were managed by simple excision than follow up. All 16 cases of Breast Abscess underwent incision and drainage and simple mastectomy was done in phylloide tumors. Conclusion: In the present study BBD occupy majority of total breast diseases. Fibro adenoma was the most common benign lesion (65.9%). FNAC was highly accurate and was highly reliable for fibro adenoma than for other lesions. Triple test is a prerequisite for determining management. However all fibro adenomas willing for surgical procedure were managed by simple excision than follow up. Conservative approach is acceptable in young patients, who choose conservative management, need to be informed about the limitation of the test, advised for proper follow up, and must be assessed properly if there are symptoms and clinical changes. Breast self examination should be emphasized as a part of female adult education.

Siniša Franjić

In most women, breast pain is not severe and disappears very quickly on its own. Severe pain, which is rare, can be relieved with medication. Benign breast diseases are common in young and older women, and malignant breast diseases most commonly occur around and after menopause. Although much rarer than benign changes, breast cancers are the most common cancers in women and represent a significant health problem. When she feels pain in her breast, the woman immediately thinks she has got breast cancer. Pain is not always a symptom of cancer. This paper discusses breast cancer, as the most common type of cancer in women, but also some other breast diseases that are not so common.

The Western journal of medicine

william goodson

Sushil Kachewar

Purpose: Cystic breast lesions are a common finding in young as well as elderly females. Although, mostly benign; they can at times be malignant too. Timely diagnosis is possible with help of Fine needle aspiration cytology (FNAC). This study was carried out with the aim of studying the panorama of various cystic breast lesions on FNAC in our setup. Materials and Methods: This was a four year prospective study carried out from May 2010 to January 2014. Cystic nature of breast mass was confirmed by palpation and by sonomammography. FNAC was then performed and the smears were stained with MGG and Papanicolaou stain. Results: Out of the 72 cases that were diagnosed to be cystic breast lesions clinically or on sonomammography, 64 were found to be benign and 08 were found to be malignant on FNAC. Retrospective imaging correlation of the 08 cystic cases revealed that they were of complex cystic nature and had either thick septae(03), solid areas (04) or dense contents (01) within. This in...

Scholar Science Journals

Background: Study of pattern of benign breast disease is a challenge due to variants in occurrence and presentation in different age groups and different geographical areas. The objective is to study the clinical profile and pattern of benign breast disease and its pathological correlation. Methods: This is a prospective study of females with breast disease presenting to surgery department over a period of one year. This survey was mainly meant for studying the age distribution, to evaluate the different types of benign diseases of the breast, their mode of clinical presentation and pathology and to evaluate the various modes of management for different types of Benign Breast Diseases. Patients with obvious malignancy and males were excluded from the study. Results: A total of 100 females were included in the study. Fibroadenoma (37%) and fibroadenosis (23%) were the commonest diseases,both presenting mostly at 21-30years of age. Left side involvement was most common. The commonest presentation was breast lump which comprised 84 (84%) cases, out of which 26 (26%) had associated complaints like breast pain and nipple discharge. Conclusion: Benign breast diseases are common problems of 2nd and 3 rd decade in females and raises considerable fear of malignancy. The patients of BBDs generally present with one or more of these complaints – breast lump, breast pain or nipple discharge. All the patients with discrete breast lumps should undergo a triple assessment to make an early diagnosis.

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Breast Cancer Case

Breast cancer case presentation, free google slides theme, powerpoint template, and canva presentation template.

Clinical cases are so convenient, the medical community is always grateful for the information provided. In this occasion, we at Slidesgo have decided to create this new presentation template, focused on breast cancer, so that you can raise awareness about this important topic and help everyone get to know what they can do.

The visuals of the slides are attractive so that all the attendees feel relaxed and at ease while you give your presentation. The main color of the template is, as you can see, a pastel pink, so its brightness will grab attention easily, making the presentation a dynamic experience. The illustrations contain flat colors and no outlines, and the style is very beautiful—your audience will like it for sure. The icons are related to health, the human body and medicine, so using them for your topic is a good idea. Of course, reports and cases like this ask for a good amount of data, but don’t worry. We’ve made sure this template has everything you could need, such as maps, graphs and tables. The slide design is optimized too, so you can organize your information and text in a proper manner. In fact, the typography helps a lot, since the serif font used for titles is ideal for screens. The typeface that you’ll find in body text, on the other hand, is a sans-serif one, and has semi-rounded details. Start customizing this template in Google Slides or PowerPoint and share what you have to say about a breast cancer clinical case.

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Studies Assess Impact of Cancer Risk-Reduction Measures for People with BRCA Changes

April 15, 2024 , by Carmen Phillips

People with harmful changes, or pathogenic variants, in the BRCA1 or BRCA2 genes have a substantially increased risk of breast and ovarian cancer.

For women in whom gene testing finds “harmful changes” in the BRCA1 or BRCA2 genes, leading medical groups recommend that they take specific actions to lower their chances of being diagnosed with or dying from breast and ovarian cancer.

Results from two recent large studies now add to findings from earlier studies suggesting that following those recommendations can reduce the risk of dying from these cancers.

In one of the studies, women with harmful changes in BRCA1 who got periodic breast MRI scans, known as MRI surveillance, were less likely to die of breast cancer in the ensuing years than those who did not . The same benefit wasn't seen in women with harmful BRCA2 changes, however.

The second study analyzed the impact of surgery known as a risk-reducing bilateral salpingo-oophorectomy , which involves removing both ovaries and fallopian tubes . Those with harmful BRCA1 or BRCA2 changes who had the surgery, the study found, had a lower risk of dying from ovarian cancer and breast cancer than those who didn’t.

Results from both studies were published February 29 in JAMA Oncology .

“These studies show that [these] cancer risk management strategies … can save lives,” wrote Meghna Trivedi, M.D., and Katrina Armstrong, M.D., of Columbia University Irving Medical Center in an editorial that accompanied both studies .

Nearly all participants in the studies were White, however, raising the question of what these results mean for women of other ethnic and racial backgrounds.

“We have to be careful about how we interpret the results” for people in these groups, said Goli Samimi, Ph.D., of NCI’s Division of Cancer Prevention , who was not involved in the study.

“Hopefully [these findings] are the impetus to do similar studies that focus on enrolling a diverse population of participants,” Dr. Samimi said.

Recommendations for genetic testing, MRI surveillance versus reality

Inherited changes in a host of genes can increase cancer risk. Perhaps of most concern for breast and ovarian cancer are harmful changes (often called pathogenic variants) in BRCA1 and BRCA2 . 

For example, 60% to 70% of people with harmful BRCA1 or BRCA2 changes will be diagnosed with breast cancer by the time they’re in their 70s, compared with only 13% of those who don’t have such changes.

BRCA Gene Mutations: Cancer Risk & Genetic Testing

What to know about the cancer risks of, and genetic testing for, mutations of the BRCA1 and BRCA2 genes.

Because of the substantial risk linked to these inherited genetic changes, leading cancer organizations recommend that people who have them consider taking measures to reduce the likelihood of developing or dying from either of these cancers, explained Tuya Pal, M.D., of the Vanderbilt-Ingram Comprehensive Cancer Center in Tennessee, a member of the study team. 

But experts on inherited cancers stress, however, that recommendations are one thing. Their use in the real world is another matter entirely. The barriers and challenges are numerous, Drs. Trivedi and Armstrong wrote. 

“First and foremost, more must be done to increase the identification of” people who have harmful BRCA1 and BRCA2 changes, in the form of more genetic testing , they wrote. 

The study’s lead investigator, Steven Narod, M.D., of Women’s College Hospital in Toronto, agreed. Recent studies show that genetic testing among at-risk people is increasing. But the fact remains, Dr. Narod said, that “too few people are getting tested.” 

For those who are able to get tested, Dr. Pal stressed that it’s critical to get counseling first by a provider with experience in genetics and cancer risk. Such counseling can help people understand what the different test results mean for them personally, including the possible risk reduction measures.

Access to licensed genetic counselors can be an issue for some people, Dr. Samimi said. One study, for example, showed that they are largely concentrated in heavily populated areas .

Getting MRI surveillance can also be a challenge. There are barriers like transportation issues and lack of access to facilities that can perform MRI scans. And despite the recommendations from medical organizations, not all insurers cover MRI surveillance of women with harmful BRCA1 and BRCA2 changes.

Given the continued challenges around the understanding of and access to recommended risk-reduction measures, Dr. Samimi said, the more evidence to support and raise awareness about them the better.

That’s where the large international research program Dr. Narod helped initiate in the mid-1990s, called the Hereditary Breast Cancer Clinical Study Group, comes in. Known as a cohort study , it was initially planned to include just a few hundred participants. It now has nearly 20,000 people with harmful BRCA1 or BRCA2 changes. 

Reductions in breast cancer deaths    

The study of MRI surveillance included about 2,500 women who participate in this larger research program. About 1,750 had MRI surveillance during the study, and on average, they had five MRIs during follow-up. 

Participants were followed for an average of about 9 years, and about 14% in both the MRI and non-MRI groups were diagnosed with breast cancer during the study.

Only a small number of participants died from breast cancer during the study. But among those with harmful BRCA1 changes, getting MRI surveillance was estimated to reduce the deaths from breast cancer over the following 20 years by about 3%. 

The reduced likelihood of dying from breast cancer in women with harmful BRCA1 changes was also seen when the comparison was restricted to women in the nonsurveillance group who had at least one mammogram during the study period.

As for the lack of a statistical reduction in breast cancer deaths for those with BRCA2 changes, it may be largely due to two factors, Dr. Narod said: the small number of participants with these changes and who had died from breast cancer.

Surgery reduces likelihood of dying from breast, ovarian cancer

The other study included nearly 4,300 women, of whom about two-thirds had had surgery. All participants had at least a bilateral oophorectomy (removal of both ovaries) and most had a salpingo-oophorectomy (removal of both ovaries and fallopian tubes). 

About 20% of all participants were diagnosed with cancer during the study period (a median follow-up of 9 years), mostly breast and ovarian cancers, and most deaths were from cancer. 

The percentage of breast cancer diagnoses were very similar between those who did and didn’t have the preventive surgery, but the percentage of ovarian cancer diagnoses was markedly higher in those who didn’t get the surgery.

Overall, participants who had oophorectomy were less likely to die from any cause, which was the study’s primary measure.

For ovarian cancer specifically, about 3.5% of those who didn’t get surgery died from ovarian cancer during the study period, compared with about 0.25% of those who did have the surgery. For breast cancer, it was 2% and 1%.

More genetic testing, maximizing risk-reducing care

Both studies, Dr. Pal said, provide strong evidence about the potential benefits of MRI surveillance or a salpingo-oophorectomy. “That’s very impactful information,” she said.

Low Rates of Genetic Testing in Ovarian, Breast Cancer

Test results can guide treatment decisions, follow-up screening.

Dr. Samimi said she’s hopeful that these new findings will further increase awareness about testing among those at risk of having inherited harmful genetic changes, and inform discussions between doctors and their patients about the options for reducing that risk.

And those conversations will hopefully extend to close blood relatives of those found to have these changes, she said.

“We have to do a better job of reaching out to families about their risk,” she continued.

NCI is funding one such effort. Called Traceback , the program is focused on helping researchers identify women who have had ovarian cancer but never got tested for cancer-related genetic changes. After they are found, they and their family members will be offered a chance to be tested. 

In Canada, Dr. Narod noted, there’s a study called the Screen Project that offers testing for harmful BRCA1 and BRCA2 changes to Canadian citizens aged 18 and older. 

Drs. Armstrong and Trivedi stressed that there’s work to do across the board to “maximize” the care needed to prevent more breast and ovarian cancer deaths. Achieving that goal, they continued, “will require providing equitable access and [insurance] coverage” of all recommended risk-reduction actions. 

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Effect of young age (below 40 years) on oncologic outcomes in Lebanese patients with breast cancer: a matched cohort study

• Eman Sbaity 1 ,
• Hani Tamim 2 ,
• Ghada El-Hajj Fuleihan 2 , 3 , 4 ,
• Jaber Abbas 1 ,
• Mariam Zahwe 5 ,
• Razan El Sayed 6 &
• Ali Shamseddine 7  

BMC Cancer volume  24 , Article number:  560 ( 2024 ) Cite this article

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Developing countries have a significantly higher incidence of breast cancer in patients younger than 40 years as compared to developed countries. This study aimed to examine if young age at diagnosis is an independent prognostic factor for worse survival outcomes in breast cancer as well as the effect of age on Disease-free survival (DFS) and local recurrence free survival (LRFS) after adjusting for various tumor characteristics, local and systemic treatments.

This is a secondary analysis of prospective cohort of patients from two existing databases. We identified patients with breast cancer aged 40 years or less and we matched them to those older than 40 years. We also matched based on stage and molecular subtypes. In cohort 1, we matched at a ratio of 1:1, while in cohort 2 we matched at a ratio of 1:3.

In cohort 1, Disease-free survival (DFS) at 5 years was significantly shorter for those younger than 40 years (75.6% and 92.7% respectively; p  < 0.03). On multivariate analysis, only chemotherapy was found to be significant, while age was not found to be an independent predictor of prognosis. Local recurrence free survival at 5 years was similar between both age categories. Only hormonal therapy is a significant predictor for LRFS at 5 years. In the second cohort, DFS and LRFS at 3 years were similar between those younger and those older than 40 years. On multivariate analysis, no factor including age was found to be an independent predictor of prognosis.

Data in the literature is controversial on the effect of young age on breast cancer prognosis. Our findings could not demonstrate that age is an independent prognostic factor in our population. There is a need for outcomes from larger, prospective series that have longer follow-ups and more data from our region.

Peer Review reports

Breast cancer is the most common cancer in females globally, with 2.3 million women diagnosed with breast cancer in 2020 [ 1 ]. Median age of breast cancer varies between developed countries of 41.9 years [ 2 ] compared to 44–48 years in developing countries [ 3 , 4 ]. As for Lebanon, the median age is 49.8 years [ 5 ].

Although breast cancer does not commonly occur in patients younger than 40 years of age, it is a leading cause of death from cancer in this young population. The proportion of young patients diagnosed with breast cancer is much higher in developing countries, 19-33.3% in Arab countries [ 6 , 7 , 8 , 9 ] compared to developed countries, 5–7% in the United States of America. This may be explained by different population pyramid, environmental or genetic factors [ 10 ].

Reports of breast cancers in young patients show higher proportions of adverse clinic-pathologic features, Her2 neu expression, Estrogen receptors (ER)- and progesterone receptor (PR)-negative tumors, and high-grade tumors that tend to be larger and to involve regional lymph nodes [ 11 , 12 , 13 ]. In addition, authors documented a different distribution of molecular breast cancer subtypes between young breast cancer and older population [ 14 ].

The effect of young age on oncologic outcomes is controversial in the literature. Initially, physicians attributed the worse prognosis of breast cancer at a younger age to an advanced stage of presentation, adverse pathologic subtypes, and less aggressive treatments [ 15 , 16 , 17 , 18 ]. This is supported by results from a large series of patients showing young age to be an independent risk factor for worse disease-free survival (DFS), Distant Disease-Free Survival (DDFS), and overall survival (OS) [ 18 , 19 ]. Other authors consider young age as a surrogate marker of more advanced stage or more aggressive phenotypes resulting in worse prognosis.

Due to the perception of a more aggressive disease, young breast cancer patients frequently receive total mastectomies. Thus, it is of high clinical importance to understand whether breast cancer surgery (BCS) is associated with a higher risk of local recurrence to better counsel young patients. Many large retrospective series showed a higher rate of local recurrence in BCS as compared to total mastectomy performed at a young age, but no difference in survival [ 18 , 20 , 21 , 22 , 23 , 24 , 25 ]. Thus, when indicated, BCS is still a viable option for young patients..

The aim of this cohort study is to examine if young age at diagnosis is an independent prognostic factor for worse survival outcomes in breast cancer as well as the effect of age on DFS and local recurrence free survival (LRFS) after adjusting for various tumor characteristics, local and systemic treatments received.

Methodology

Study design.

We conducted a secondary analysis of two existing prospective cohorts of breast cancer patients. We matched patients younger than 40 years to those older than 40 years at a ratio of 1:3. We matched cases based on the stage of breast cancer at presentation and molecular subtypes.

Data sources

The study is a secondary analysis of two existing databases. The first is prospectively collected data of all Lebanese non-metastatic breast cancer patients who received any part of their treatment at the American University of Beirut Medical Center (AUBMC) between the years 2011–2014 to study the difference in outcomes between the two age groups (IRB study #IM.AS.17). It includes 123 Lebanese patients (with 47 patients below the age of 40 years). The second is an IRB-approved prospectively collected database of the clinical research unit at Basile Cancer Institute at AUBMC (BIO-2018-0302), including all consecutive breast cancer patients who have presented to AUBMC from October 2014 to December 2016. Informed consent to participate in the initial studies was obtained from all participants. We performed a comparison between both datasets regarding tumor characteristics and received treatments. This revealed statistically significant differences in both populations, so we decided to analyze each cohort separately.

Eligibility criteria

We included patients with:

Non-metastatic biopsy-proven breast cancer.

Lebanese women, older than 18 years.

Received any part of their treatment or followed up at AUBMC.

We excluded:

Male breast cancer patients.

Patients with unclassified tumor.

Patients with missing data on stage or ER, PR, or Her2 NEU or staging information.

Sampling Frame

At our institution, breast cancer patients are treated by dedicated breast surgical oncologists, breast medical oncologists, and breast radiation oncologists, ensuring similar and up-to-date treatment plans based on National Comprehensive Cancer Network (NCCN) guidelines, American Society of Cancer Oncology (ASCO), and ASBS (American Society of Breast Surgery). In addition, most of these patients are discussed in the weekly Breast Tumor Board before initiation of treatments.

Outcome measures

Primary outcome:

DFS at 3 years, defined by survival without clinical or radiological evidence of recurrence of disease, whether local, distant, or both.

Secondary outcomes:

Local recurrence Free Survival at 3 years (LRFS) defined by clinical or radiological evidence of disease in the affected breast or regional nodal basin.

Overall Survival (OS) at 3 years defined from time of diagnosis till date of death or last follow up.

Distant Metastasis Free Survival (DMFS) is defined from the date of diagnosis till the date of distant metastasis or till the date of last follow up in patients who did not experience metastasis.

Effect of various tumor grade, local and systemic treatments received on DFS, LRFS, and DMFS.

Statistical analysis

We conducted all analyses using SPSS Version 24, and statistical significance was assumed at a p  < 0.05. Prognostic factors were compared between the two groups using chi-square test for categorical variables and independent t-test for continuous variables. We estimated DFS, LRFS, DMFS, and OS, using Kaplan–Meier method and Log-Rank test for the different survival curves between both age categories. We then performed a univariate analysis comparing the effect of each grade of tumor, chemotherapy, Hormonal therapy, Herceptin, type of surgery, radiation therapy, and BMI on DFS, LRFS, and DMFS at three years follow up. We used Cox regression analysis to assess how survival outcomes change between both age groups after controlling for grade of tumor, chemotherapy, hormonal therapy, Herceptin therapy, surgery type, and radiation therapy. COX Regression was done using the forward and backward methods.

Description

The first cohort included 122 breast cancer patients, 77 patients above the age of 40 years, and 45 patients below or equal to 40 years. We performed 1:1 matching, where 41 breast cancer patients aged 40 or younger were matched to 41 breast cancer patients older than 40. The patients’ molecular subtypes and stages are shown in Table  1 .

Comparison of treatments received

Total mastectomy was performed only in onethird of patients above 40 years as compared to 56% of patients below 40 years with p  = 0.026. Radiotherapy and chemotherapy were administered in a similar proportion for both groups without any statistical difference. A higher proportion of patients in the younger subgroup received trastuzumab as compared to the older subgroup, 30% and 12.2% respectively ( p  = 0.049). Similarly, patients in the younger subgroup are more likely to receive hormonal therapy, but without reaching a statistical significance. (Table  1 )

Only one death is documented in the older subgroup, and two deaths in the younger subgroup. Local recurrence is double in the younger age group, with 6 local recurrence events (14.6%) compared to 3 local recurrence events (7.3%) in the older age group. Distant metastasis occurred more in the younger age groupin 9 patients (22%) compared to 6 (14.6%) in the older age group.

Survival analysis

DFS at 5 years : in young patients, the DFS is 75.6% compared to 92.7% in older patients with p  = 0.035. In patients who received chemotherapy, DFS is lower in the younger age group,74.1% compared to 100% in those older than 40 years, with a statistically significant p -value of 0.005. Similarly, in patients who received hormonal therapy, DFS is lower in the younger subgroup of patients, at76.5% compared to 96.8%, with a p -value of 0.016. On multivariate analysis, only chemotherapy was an independent prognostic factor for DFS at 5 years. Age was not found to be an independent prognostic factor for DFS. (Table  2 )

LRFS at 5 years : among those above 40 years, the is 92.7% (3 local recurrence events) and 87.8% (5 local recurrence events) among those below or equal to 40 years ( p  = 0.361).

We did not find any clinically or statistically significant difference when stratifying LRFS at 5 years according to the different loco-regional and systemic therapies. Patients who underwent partial mastectomy have an LRFS of 96.4% in the older group and 94.4% in the younger group, with no statistical significance ( p  = 0.655). For those who underwent total mastectomy, LRFS is 84.6% and 82.6% in the older and younger group, respectively ( p  = 0.821). In multivariate cox regression analysis, only hormonal therapy was found to be a predictor for worse LRFS at 5 years, while age was not found to be an independent prognostic factor.

OS at 5 years : in the above 40 years group, the overall survival at 5 years is 97.6% and 95.1% in the below or equal to 40 years group, with no statistical significance ( p  = 0.490) (Table  3 ).

There are a total of 399 patients in cohort 2, with 55 breast cancer patients aged 40 or younger matched to 165 breast cancer patients older than 40 years, at a 1:3 ratio. In the older age group, a total of 40 patients (28%) had grade 3 breast cancer, compared to 22 patients (44%) in the younger age category with a significant p -value of 0.03 (Table  4 ).

Mastectomy was performed more frequently in the older group, but the difference is not statistically significant ;76 (46.6%) patients above 40 years underwent total mastectomy as compared to 20 (37%) patients below 40 years ( p  = 0.219). For radiation therapy, 67.7% of patients over 40 years received radiotherapy, and 64.8% of patients in the younger group ( P  = 0.698). Both age subgroups received chemotherapy in a similar proportion, with 74.4% of patients in the above 40 years groupand 77.4% in the below or equal to 40 years group ( p -value of 0.663). A higher proportion of patients in the younger subgroup received trastuzumab and hormonal therapy as compared to the older subgroup but without reaching statistical significance. A total of 81.3% of patients younger than 40 years received hormonal therapy compared to 69.7% of patients older than 40 years ( p  = 0.119).

No deaths are documented in any subgroup. Local recurrence did not occur in the younger group, and only 1 event (0.6%) occurred in the older group. Distant metastasis occurred in 1 patient (1.8%) in the below 40 years subgroup and in 6 patients (3.6%) in the older age group.

DFS at 3-years : is slightly shorter for the younger age patient category but without reaching statistical significance (97% versus 98.2%; p  = 0.621). DFS is 100% for partial mastectomy in the younger group and 97.7% (2 events) in the older group ( p  = 0.346). Among patients treated with total mastectomy, DFS is 97.4% in the older group and 95% in the younger group, with no statistical significance ( p  = 0.645). On multivariate Cox regression analysis for DFS at 3 years for cohort 2, no factor was found to be a significant predictor of survival.

LRFS at 3 years : local recurrence occurred only in 1 patient (99.4%) in the younger group and none in the older group. ( p  = 0.537). On multivariate Cox regression analysis for cohort 2, no factor was found to be a significant predictor of survival for LRFS at 3 years.

In our first cohort, the distribution of early and advanced breast cancer was similar. In the second cohort, older breast cancer patients were more likely to be present in the early stages. This result was similar to that reported by many authors who mentioned that young patients with breast cancer present with a more aggressive clinical picture and advanced stage as compared to older patients. Cancers in the younger age group are usually detected by the patients themselves and,consequently, are often bigger in size and more advanced than the screen-detected tumors in those above 40 years [ 26 , 27 ].

We had a similar proportion of molecular subtypes in both age categories, with a slightly higher proportion of Triple negative molecular subtype in our young patient population. This is different from the proportions known for breast cancer patients. The literature reports on a difference in the distribution of breast cancer molecular subtypes between younger and older patients [ 14 , 28 ]. Variability in molecular subtyping among different populations may be due to variability in pathology reviews and different definitions to categorize the 4 subtypes, where mainly the confusion happens with deciding on luminal A and B.

Age was not found to be an independent prognostic factor in our cohort of patients, which is matched for stage and molecular subtype and after adjusting for treatments received. DFS after 5 years was statistically lower in the younger group. However, LRFS at 3 years and 5 years were not statistically different between both age categories. Nixon et al. reported similar results where young breast cancer has a higher local recurrence rate and inferior DFS [ 12 , 13 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 ]. Recurrence events in breast cancer usually happen at a median of 32 months, which falls within our follow-up period. Nevertheless, a longer follow-up is required to make a solid conclusion.

When we stratified the outcomes according to the type of surgery done, there was no significant difference in the DFS at 3 and 5 years and LRFS at 3 years in both age categories. This result was similar to the National Cancer Institute randomized study that showed similar local recurrence between both arms of treatment for BCS and total mastectomy [ 38 , 39 ]. Age was not found to be a predictor of local recurrence when total mastectomy was performed. However, in the Institut Gustave-Roussy Breast Cancer Group Distribution of local recurrence based on age grouping of less than and more than 40 years, there was a three times higher rate of local recurrence in the younger patients with BCS.

On univariate analysis of cohort 1, patients receiving radiotherapy and those below 40 years had lower 5-year DFS, but this difference was not statistically significant ( p  = 0.093). We cannot compare our results to the literature because the majority of studies did not report on the use of radiation therapy after BCS, so we cannot identify those local recurrences secondary to lack of radiation. Similarly, it is not possible to discern the effect of post mastectomy radiation on preventing local recurrences.

In the strata of patients who received chemotherapy, DFS is lower in the younger age group, 74.1% compared to 100%, in those older than 40 years, with a statistically significant p -value. On multivariate analysis, only chemotherapy was an independent prognostic factor for DFS at 5 years. Age was not found to be an independent prognostic factor for DFS. Similarly, we did not find a statistically significant difference when we stratified LRFS at 5 years for the chemotherapy treatments. On the contrary, the Beadle et al. study [ 40 ] showed that local therapies did not affect the rate of local recurrence in young patients, but systemic therapy did affect it with statistical significance. This speaks about a different biology in young patients, where perhaps even in stage I, chemotherapy should be given to improve oncologic outcomes.

In the strata of patients in cohort 1, patients who received hormonal therapy had statistically significant lower DFS at 5 years in the younger subgroup of patients but not for LRFS at 5 years. On multivariate Cox regression analysis, only hormonal therapy was found to be a predictor for worse LRFS at 5 years, while age was not found to be an independent prognostic factor. ER-positive is reported in the literature to be associated with worse prognosis in the younger population. Some attribute this to the fact that young patients were not treated with hormonal therapy until recently. Consequently, the worse prognosis observed in the young population of ER-positive cancermay be due to the differential use of Tamoxifen. In addition, even after treating young breast cancer patients with Tamoxifen, there is high non-compliance. This was demonstrated by a systematic review by Murphy et al. [ 41 ].

Among those who received trastuzumab, LRFS is 100% in the older group and 83.3% in the younger group ( p  = 0.315). For those who did not receive trastuzumab, LRFS is similar, with 91.7% in the older group and 89.3% in the younger group, with no statistical significance ( p  = 0.629). Many studies that explored local recurrence in a large cohort of breast cancer patients included patients from the era before the introduction of trastuzumab in the treatment of Her 2 positive breast cancer. This is a major limitation of such studies because trastuzumab dramatically improved in oncologic outcomes when indicated.

Strengths and limitations

This study aimed to fill a gap in the literature where there is limited data from the modern era of effective surgery, chemotherapy, hormonal, and radiation therapy in young patients. The reported data on the effect of age on breast cancer outcomes is widely retrospective; our data is prospectively collected. Another strength of our study is matching the two age cohorts on the two most important baseline prognostic factors (stage and molecular phenotype). Data on local recurrence after BCT in young patients mainly camefrom series collected over long periods of time and did not receive the modern modalities of breast cancer treatments. Our cohort of patients is a modern cohort treated based on modern therapies.

Because there is no breast cancer national comprehensive database, we could not compare our cohort characteristics to national and thus decide on the generalizability of our results. We have a limited follow-up period for our patients, where the majority reach only 3 years of follow-up.

Data availability

The datasets analyzed in the current study are available on request from the corresponding author.

Abbreviations

Estrogen Receptors

Progesterone Receptor

Disease Free Survival

Distant Disease-Free Survival

Overall Survival

Breast Cancer Surgery

Local Recurrence Free Survival

American University of Beirut Medical Center

Human Epidermal Growth Factor Receptor 2

National Comprehensive Cancer Network

American Society of cancer Oncology

American Society of Breast Surgery

Distant Metastasis Free Survival

Breast-conserving therapy

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Acknowledgements

The authors acknowledge the contribution of Ahmad Najia and Nadia Hoyek who were involved in this research under the Medical Research Volunteer Program (MRVP) at the American University of Beirut.

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Methodology: E.S, H.T, G.E, A.S; Resources: A.S, J.A; Data Curation: E.S; Data Analysis: E.S, H.T; Writing - original draft: E.S; Writing – review & editing: H.T, G.E, A.S, J.A, M.Z, R.E. All authors read and approved the final manuscript.

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Sbaity, E., Tamim, H., El-Hajj Fuleihan, G. et al. Effect of young age (below 40 years) on oncologic outcomes in Lebanese patients with breast cancer: a matched cohort study. BMC Cancer 24 , 560 (2024). https://doi.org/10.1186/s12885-024-11910-w

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Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Phase III trial

Astrazeneca and daiichi sankyo’s enhertu also demonstrated a clinically meaningful progression-free survival improvement in patients with her2-ultralow expression  .

Positive high-level results from the DESTINY-Breast06 Phase III trial showed that Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy.

A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC >0<1+] metastatic breast cancer). A prespecified subgroup analysis showed the clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow expression.

Overall survival (OS) data were not mature at the time of the analysis; however, Enhertu showed an early trend towards an OS improvement versus standard-of-care chemotherapy in patients with HER2-low metastatic breast cancer and in the overall trial population. The trial will continue as planned to further assess OS and other secondary endpoints.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “DESTINY-Breast06 shows that Enhertu could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “The topline results from DESTINY-Breast06 highlight the importance of continuing to challenge current treatment paradigms and established breast cancer classifications to evolve how we treat patients with HR-positive, HER2-expressing metastatic breast cancer. Building on the practice-changing data seen in DESTINY-Breast04, these results reinforce the potential for use of Enhertu earlier in the treatment landscape and in an even broader patient population.”

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

It is estimated that approximately 60-65% of HR-positive, HER2-negative breast cancers are HER2-low and potentially an additional 25% may be HER2-ultralow. 1,2   Endocrine therapies are widely used in the early lines of treatment for HR-positive metastatic breast cancer; however after two lines of treatment, further efficacy from endocrine therapy is often limited. 3 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes. 3-6

The safety profile of Enhertu was consistent with previous breast cancer clinical trials with no new safety signals identified.

The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

DESTINY-Breast06 DESTINY-Breast06 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining; IHC >0<1+) advanced or metastatic breast cancer. Patients in the trial had no prior chemotherapy for advanced or metastatic disease and either experienced disease progression within 6 months of starting 1st-line treatment with an endocrine therapy combined with a CDK4/6 inhibitor or received at least two previous lines of endocrine therapies in the metastatic setting.

The primary endpoint is PFS in the HR-positive, HER2-low patient population as measured by blinded independent central review (BICR). Key secondary endpoints include OS in patients with HER2-low expression and PFS by BICR and OS in the overall trial population (HER2-low and HER2-ultralow). Other secondary endpoints include objective response rate, duration of response, time to first subsequent treatment or death, time to second subsequent treatment or death and safety. Analysis of the HER2-ultralow subgroup was not powered to demonstrate statistical significance.

DESTINY-Breast06 enrolled 866 patients (n=713 for HER2-low and n=153 for HER2-ultralow) at multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov .

Breast cancer and HER2 expression Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 7 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally. 7 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or progress to metastatic disease are expected to live five years after their diagnosis. 8

HR-positive, HER2-negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers. 8 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer. 9 Patients with high levels of HER2 expression (IHC 3+ or 2+/ISH+) are classified as HER2-positive and treated with HER2-targeted therapies, representing approximately 15-20% of all breast cancers. 10 Historically, tumours that were not classified as HER2-positive were classified as HER2-negative; however, many of these tumours still carry some level of HER2 expression. 11 It is estimated that approximately 60-65% of HR-positive, HER2-negative breast cancers are HER2-low and potentially an additional 25% may be HER2-ultralow. 1,2

Prior to the approval of Enhertu in HER2-low metastatic breast cancer post chemotherapy based on the DESTINY-Breast04 trial, there were no targeted therapies approved specifically for patients with HER2-low expression. 12 There are no targeted therapies specifically approved for patients with HER2-ultralow expression.

Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) is approved in more than 60 countries for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or 2+/ISH+) breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 60 countries for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 35 countries for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 40 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 and/or DESTINY-Gastric02 trials.

Enhertu (5.4 mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and who have no satisfactory alternative treatment options based on results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials.

Enhertu development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.

Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and datopotamab deruxtecan in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap , and next-generation SERD and potential new medicine camizestrant. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is evaluating the potential of datopotamab deruxtecan alone and in combination with immunotherapy Imfinzi (durvalumab), Truqap in combination with chemotherapy, and Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu .

AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . 

For details on how to contact the Investor Relations Team, please click here . For Media contacts, click here . 

1. Denkert C, et al. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Oncol. 2021 Aug;22(8):1151-1161.

2. Chen Z, et al. Is HER2 ultra‑low breast cancer different from HER2 null or HER2 low breast cancer? A study of 1363 patients. Breast Cancer Res Treat . 2023 Nov;202(2):313-323.

3. Manohar P, et al. Updates in endocrine therapy for metastatic breast cancer. Cancer Biol Med . 2022 Feb 15; 19(2):202–212.

4. Cortes J, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377:914-923.

5. Yuan P, et al. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer . 2019;112:57–65.

6. Jerusalem G, et al. Everolimus Plus Exemestane vs Everolimus or Capecitabine Monotherapy for Estrogen Receptor–Positive, HER2-Negative Advanced Breast Cancer. JAMA Oncol . 2018;4(10):1367–1374.

7. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.  CA Cancer J Clin . 2024 Apr 4. doi: 10.3322/caac.21834.

8. National Cancer Institute. Surveillance, Epidemiology and End Results Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html . Accessed April 2024  

9. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int . 2014;852748.

10. Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med. 2020;54(1):34-44.

11. Sajjadi E, et al. Improving HER2 testing reproducibility in HER2-low breast cancer. Cancer Drug Resist. 2022;5(4):882-888.

12. Modi S, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022;387:9-20.

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