On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for use in adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

On May 4, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu^®) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2–based regimen in the metastatic setting as well as those in the neoadjuvant or adjuvant setting who developed disease recurrence during or within six months of completing therapy.

Patients younger than 40 who elected to have breast-conserving surgery instead of mastectomy to remove breast cancer reported having better quality of life (QOL) more than five years after diagnosis, according to study findings reported in JAMA Surgery.

On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza^®) for adult patients with deleterious or suspected deleterious germline BRCA variant (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are selected for therapy based on an FDA-approved companion diagnostic for olaparib.

PALB2 refers to partner and localizer of BRCA2. The gene was isolated in 2007 and is the third most common gene associated with breast cancer risk. Both men and women are at increased risk for developing multiple cancers if they have a pathogenic PALB2 variant (see sidebar).

A new risk model tailored for Black patients predicts their risk of developing breast cancer as accurately as current models for White patients, researchers reported in the Journal of Clinical Oncology. Because Black patients are more likely to be younger at diagnosis, present with aggressive or advanced cancer, and die from the disease than other racial and ethnic groups, using the new model to personalize prevention and screening recommendations may reduce those disparities.

Biomarker testing is an essential tool when choosing the right treatment for many advanced solid cancers. However, tissue-based testing may take weeks to get results with a chance that not enough tissue was collected to complete the entire biomarker panel. Blood draw–based liquid biopsies may be a useful alternative to identify a tumor’s biomarker details and can be performed by testing for circulating tumor DNA (ctDNA).

Combining a CDK4/6 inhibitor and fulvestrant improves overall survival consistently among patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer, according to a U.S. Food and Drug Administration (FDA) analysis. The agency reported the findings in Lancet Oncology.

On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio^®) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk for recurrence and a Ki-67 score ≥ 20%, as determined by an FDA-approved test. This is the first CDK4/6 inhibitor approved for adjuvant treatment of breast cancer.  

Initially marketed in April 2020 for treatment of adults with metastatic triple negative breast cancer, sacituzumab govitecan-hziy (Trodelvy^®) received an additional approval in 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer with prior treatments.

Ophelia is a 42-year-old patient who has been diagnosed with triple-negative breast cancer (TNBC). She completed neoadjuvant chemotherapy with dose-dense doxorubicin and cyclophosphamide, followed by paclitaxel and carboplatin. Her postsurgical pathology shows residual disease in the tumor (3.5 cm down from 4 cm) and 12 out of 18 lymph nodes that are positive for cancer. Ophelia tells you that she is very discouraged and expected a better treatment outcome.

In April 2021, U.S. Senators Chris Murphy (D-CT) and Joni Ernst (R-IA) introduced the Metastatic Breast Cancer Access to Care Act, legislation that would waive the five-month waiting period for social security disability insurance (SSDI) and the 24-month waiting period for eligible Medicare benefits.

On July 26, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and continued as a single agent as adjuvant treatment after surgery. 

Using positron-emission tomography with a radioactive tracer identifies levels of progesterone receptor in patients with estrogen receptor-positive breast cancer, researchers reported in Nature Communications. The diagnostic tool would help clinicians determine which patients are most likely to respond to hormone therapies for breast cancer.

On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy^®) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who received two or more prior systemic therapies, at least one of which for metastatic disease.

On March 31, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication informing patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.

In 2019, PI3K inhibitors became a new treatment option for postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer with the U.S. Food and Drug Administration’s approval of alpelisib in combination with fulvestrant. Although alpelisib remains the only PI3K inhibitor approved today, others are in clinical trials, and the new class of agents has a unique safety profile.

More than 3.5 million people in the United States are living with a breast cancer diagnosis. Despite their large number, patients often report they do not receive appropriate follow-up care after completing treatment—and the situation is worsening, with pandemic-related delays in care affecting approximately half of breast cancer survivors.

On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza™) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who previously received two or more anti-HER2 regimens, at least one of which was for metastatic disease.

On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test. FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic for selecting patients with TNBC for pembrolizumab.

In the United States, breast cancer is the most commonly diagnosed cancer in women. One in eight women will develop invasive disease in their lifetime with approximately 270,00 new cases diagnosed in the United States in 2019. Caucasian women have the highest incidence rate, whereas African American women are most likely to die from the disease. The five-year survival rate is 91%, with an estimated 3.8 million breast cancer survivors living in the United States.

On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq^®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.   

Thanks to expanded Medicaid coverage from the Affordable Care Act (ACA), women diagnosed with breast cancer—and in particular, African American women who are more likely to experience breast cancer disparities—are getting their cancers found at earlier stages, according to researchers. The study findings were reported in JAMA Surgery.

Black women with breast cancer typically have a worse prognosis than white women, and the results of a new study suggest that insulin resistance may be a factor in the disparity. Findings from the study were reported in Breast Cancer Research.

Antioxidant supplements are associated with increased disease recurrence and statistically nonsignificant increased risk of mortality in patients with breast cancer who were receiving cyclophosphamide, doxorubicin, and paclitaxel, according to findings from a study reported in the Journal of Clinical Oncology.

On April 17, 2020, as part of Project Orbis, the U.S. Food and Drug Administration (FDA) approved tucatinib (Tukysa™) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery or have spread to other parts of the body, including the brain, and who have received one or more prior treatments. 

Two new drugs in clinical trials are extending survival for women with metastatic HER2-positive breast cancer that had progressed with previous treatment. One of the drugs was effective for brain metastasis, which is particularly difficult to treat. Results from both studies were reported in the New England Journal of Medicine. 

The Adjuvant Radiotherapy Intensification Classifier (ARTIC) predicts which women with early-stage breast cancer will benefit the most from radiotherapy, as well as their risk for locoregional recurrence after radiation, researchers reported in study findings published in the Journal of Clinical Oncology. 

Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in Latina women. Compared to all patients with breast cancer, Latinas are the second most common ethnic group to carry BRCA1 deleterious mutations, after Ashkenazi Jewish women. However, Latinas are less likely to receive genetic counseling education, referrals, and testing services and have the least awareness of genetic testing compared to non-Hispanic whites and other minority populations. Research indicates that despite their low awareness, Latinas have high interest in participating in genetic counseling and testing. 

On February 25, 2020, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlyn®) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Men have higher death rates than women across all stages of breast cancer, study findings reported in JAMA Oncology show. In the study, five-year overall survival after a breast cancer diagnosis was 77.6% for men and 86.4% for women.

According to findings from a new analysis published in JAMA Oncology, multigene testing should be expanded to all women with breast cancer and not just those with certain family histories or clinical factors.

Lymphedema is one of the most common treatment side effects in patients with breast cancer. Estimates suggest that approximately 40% of all breast cancer survivors are at risk to develop lymphedema at some point in their lives. But as far back as 1998 and even before, some healthcare experts were predicting that lymphedema would be eliminated as a side effect from breast cancer treatment. Twenty-one years later, it’s still prevalent among breast cancer survivors, requiring careful management recommendations from oncology nurses to help patients live with this chronic issue.

Combination treatment with a CDK4/6 inhibitor and aromatase inhibitor (AI) results in similar progression-free survival (PFS) rates in women with hormone receptor-positive, HER2-negative metastatic breast cancer who are aged 70 or older compared to younger women, according to study findings published in the Journal of Clinical Oncology.

Certain groups of women who are at increased risk for carrying BRCA1 or BRCA2 genes should be assessed for the need for genetic testing, and women at increased risk for breast cancer and low risk of adverse events should be offered risk-reducing medications, the U.S. Preventive Services Task Force (USPSTF) recommended.

Although death rates from breast cancer have been falling, the trend has not been equal among all women. Looking at breast cancer survival on a population level can tell us how effective our public health and healthcare systems are at early diagnosis, delivery of evidence-based treatment, and management of follow-up care.

Women who survived pediatric cancer but developed breast cancer as an adult are more than twice as likely to die prematurely, mostly from comorbid conditions, according to results of a study published in the Journal of Clinical Oncology.

Health care is the top domestic policy issue for Americans, but with so many different ideas to make the healthcare system more accessible and affordable, the issue is becoming increasingly complex. Because of its far-reaching impact, health care is often a politically charged topic and little change has yet been seen on a legislative level.

The U.S. Food and Drug Administration (FDA) first approved atezolizumab (Tecentriq^®) in 2016, but it received additional approvals when used in combination treatments for locally advanced or metastatic triple negative breast cancer (TNBC) and small cell lung cancer (SCLC) in March 2019.

A prediction test accurately identifies which women with estrogen receptor (ER)-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy, according to the results of a study published in Breast Cancer Research and Treatment. 
 

People with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma (ALCL), the U.S. Food and Drug Administration (FDA) announced in April 2019. Typically the cancer is limited to the scar tissue and fluid near an implant, but some patients experience spread throughout the body. The risk increases with textured implants in particular.

On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray®) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Unlike other types of breast cancer, a triple-negative diagnosis doesn’t have any of the common receptors found in other breast cancers, presenting potential treatment challenges to patients and providers. To assist patients with triple-negative breast cancer, the Centers for Disease Control and Prevention (CDC) created a new virtual program, allowing patients to consult and ask questions to a virtual coach in the comfort of their own homes.

After completing neoadjuvant chemotherapy for triple-negative invasive breast cancer, Madeline, age 32, had a bilateral mastectomy with reconstructive surgery. Final pathology showed residual disease in the breast and one lymph node, and her oncologist recommended adjuvant therapy with capecitabine (1,500 mg twice a day for 14 days, off for 7 days). Five weeks postoperatively, she started cycle 1. Eight days later, her husband called the cancer clinic reporting that over the past two days, his wife developed profound weakness, unremitting diarrhea despite using diphenoxylate and atropine as directed, and painful, red, swollen hands and feet. Her symptoms represented a drastic change from her usual routine and energy level.

On May 3, 2019, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kakcyla®) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.

On February 28, 2019, the U.S. Food and Drug Administration (FDA) approved a trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta). The drug is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.