Breast cancer, PIK3CA-mutated

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

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

Hormonotherapy

  • 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

References

  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 NCT02437318

Fulvestrant monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
André et al. 2019 (SOLAR-1) 2015-2017 Phase III (C) Alpelisib & Fulvestrant Inferior PFS
Dent et al. 2020 (SANDPIPER) 2015-2017 Phase III (C) Taselisib & Fulvestrant Inferior PFS

Note: patients enrolled in these trials had HR-positive breast cancer.

Hormonotherapy

  • 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

References

  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 NCT02437318
  2. SANDPIPER: Dent S, Cortés J, Im YH, Diéras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. Epub 2020 Nov 10. link to original article PubMed NCT02340221