Breast cancer, PIK3CA-mutated
|H. Deepika Fernandes, MD, FACP|
University of North Dakota
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
|back to top|
|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.
- Alpelisib (Piqray) 300 mg PO once per day
- 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
- 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