Trastuzumab (Herceptin - Genentech), a recombinant 'humanized' monoclonal antibody (rhuMAb) that binds to a protein encoded by the oncogene HER2, and capecitabine (ka pe site' a been; Xeloda - Roche), an oral pro-drug for 5-fluorouracil, have been approved by the FDA for treatment of metastatic breast cancer.

Docetaxel (Taxotere - Rh ne-Poulenc Rorer), a semisynthetic taxoid similar to paclitaxel (Taxol - Medical Letter, 35:39, 1993), has been approved by the US Food and Drug Administration for use in locally advanced or metastatic breast cancer that has progressed or relapsed during treatment that included an anthracycline such as doxorubicin (Adriamycin, and others).

Fulvestrant (Faslodex -- AstraZeneca), an estrogen receptor antagonist given intramuscularly (IM) once a month, was recently approved by the FDA for treatment of hormone-receptor-positive metastatic breast cancer in postmenopausal women with disease progession on tamoxifen (Nolvadex, and others) or another antiestrogen.

Lapatinib (Tykerb - GlaxoSmithKline), an oral inhibitor of both HER-2 and epidermal growth factor receptor type 1 (EGFR-1 or ErbB-1), has been approved by the FDA for use in combination with capecitabine (Xeloda) to treat advanced or metastatic breast cancer that overexpresses HER-2 in patients who have received prior therapy that included an anthracycline, a taxane and trastuzumab (Herceptin), an intravenous monoclonal antibody that also inhibits HER-2.

The most important prognostic variable in early breast cancer is axillary lymph node involvement. Based on past experience, after 10 years about 70% of node-negative patients will be alive and apparently free of disease; about 30% will have relapsed or died. Patients with positive nodes may have a 30% to 60% relapse rate, depending on the number of positive nodes and other prognostic factors, such as the presence of estrogen receptors (IC Henderson et al, in VT DeVita, Jr et al, eds, Cancer: Principles and Practice of Oncology, 3rd ed, Philadelphia:Lippincott, 1989, p 1197). Which of...

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%.

The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...

The FDA has approved elacestrant (Orserdu – Stemline), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer in postmenopausal women or men who had disease progression following endocrine therapy. Elacestrant is the first oral selective estrogen receptor degrader (SERD) to be approved for treatment of breast cancer; the injectable SERD fulvestrant (Faslodex, and generics) was approved more than 20 years...

Interim results of a double-blind, placebo-controlled trial suggest that off-label use of the anticholinergic drug oxybutynin may reduce the frequency and severity of hot flashes in women with breast cancer. Extended-release oral oxybutynin (Ditropan XL, and generics) has been shown to reduce the frequency and severity of hot flashes in healthy menopausal women.

The FDA has approved the oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) for extended adjuvant treatment of adults with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer, following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur.