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Content Update

June 3, 2019

Alpelisib Approved for PIK3CA Mutated Breast Cancers: Alpelisib (Piqray®) is the first PI3K inhibitor approved by the FDA and is indicated for adults with hormone receptor (HR) positive and human epidermal growth factor (HER2) negative advanced or metastatic breast who have progressed on prior endocrine therapy. PIK3CA mutations are common, occurring in about 35% of all breast cancers. In the SOLAR-1 trial, the median progression free survival was 11.0 months in the alpelisib arm compared to 5.7 months in the placebo group (HR 0.65, 95% CI 0.50–1.25, P=.00065). Overall response rate is 36%, compared to 16% in the placebo group. The most common adverse effects are hyperglycemia, nausea and rash.


For the chapter in the Wells Handbook, please go to Chapter 60. Breast Cancer.



  • image Breast cancer is usually diagnosed in the early stages when it is a highly curable malignancy.

  • image Although controversial, regular screening mammography in women younger than 50 years of age is beneficial, and many national and international studies demonstrate a reduction in the breast cancer mortality rate from annual or biennial screening mammography in women ages 50 to 74 years.

  • image Local therapy of early-stage breast cancer consists of modified radical mastectomy or lumpectomy plus external-beam radiation therapy. The surgical approach to the ipsilateral axilla may consist of a lymph node mapping procedure with sentinel lymph node biopsy or a full level I/II axillary lymph node dissection.

  • image Adjuvant endocrine therapy reduces the rates of relapse and death in patients with hormone receptor–positive early breast cancer. Adjuvant chemotherapy reduces the rates of relapse and death in all patients with early-stage breast cancer.

  • image The choice of the most appropriate chemotherapy, endocrine therapy, and anti-HER2 therapy regimen is complex and rapidly changing as results from ongoing randomized clinical trials are reported.

  • image Neoadjuvant chemotherapy and biotherapy are appropriate for selected patients with early breast cancer and most patients with locally advanced breast cancer and inflammatory breast cancer followed by local therapy and further adjuvant systemic therapy as indicated.

  • image Whereas the goal of adjuvant and neoadjuvant chemotherapy is curative, the goal of chemotherapy in the metastatic setting is palliative.

  • image Anti-HER2 therapies and other biologic or targeted agents (eg, everolimus, palbociclib) in combination with chemotherapy or endocrine therapy have significantly improved outcomes for selected patients with metastatic breast cancer (MBC).

  • image Initial therapy of metastatic breast cancer in most women with hormone receptor–positive tumors should include endocrine therapy.

  • image About 60% of women with metastatic breast cancer will respond to chemotherapy regimens; anthracycline- and taxane-containing regimens are the most active.

Breast cancer is the most common site of cancer and is second only to lung cancer as a cause of cancer death in American women. It was estimated that 249,260 new cases of breast cancer will be diagnosed and that 40,890 people will ...

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