Breast cancer, PIK3CA-mutated

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H. Deepika Fernandes, MD, FACP
University of North Dakota
Bismarck, ND
1 regimens on this page
1 variants on this page

Note: this page has regimens which are specific to breast cancer that is PIK3CA-mutated. Please see the main breast cancer page for other chemotherapy regimens.

Advanced or metastatic disease, all lines of therapy

Alpelisib & Fulvestrant

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FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
André et al. 2019 (SOLAR-1) 2015-2017 Phase III (E-RT-esc) Fulvestrant Superior PFS

Note: patients enrolled in this trial had HR-positive breast cancer.

Targeted therapy


  • Fulvestrant (Faslodex) as follows:
    • Cycle 1: 500 mg IM once per day on days 1 & 15
    • Cycle 2 onwards: 500 mg IM once on day 1

28-day cycles


  1. SOLAR-1: André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Pápai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. link to original article contains verified protocol PubMed