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Breast Cancer

Two human genes, BRCA1 and BRCA2 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer.
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
The large, randomized TAM-01 clinical trial demonstrated that 5 mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo.
Analysis of a phase 3 clinical trial showed that 6 months of trastuzumab was noninferior to 12 months in terms of disease-free survival, and was also associated with a 50% reduction in cardiotoxicity.

The novel drug sacituzumab govitecan is showing significant promise in HER2-negative breast cancers. “The benefit was durable, with an estimated medical duration of response of 7.4 months,” reported Aditya Bardia, MD, MPH.

A new study presented at the 2018 American Association for Cancer Research meeting suggests that HER2 mutations can be acquired during metastatic cancer and their development represents a previously unreported mechanism of resistance to treatment.
A new study presented at the 2018 American Association for Cancer Research meeting suggests that HER2 mutations can be acquired during metastatic cancer and their development represents a previously unreported mechanism of resistance to treatment.
Dr Thomas Bachelot is careful to set reasonable expectations for his patients with HR+/HER2- metastatic breast cancer regarding how long their treatment will last and how it will impact them.
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