Breast cancer, PIK3CA-mutated
Revision as of 14:07, 15 February 2022 by Jwarner (talk | contribs) (→Advanced or metastatic disease, all lines of therapy)
3 regimens on this page
3 variants on this page
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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 3 (E-RT-esc) | Fulvestrant | Superior PFS |
Note: patients enrolled in this trial had HR-positive breast cancer.
Targeted therapy
- Alpelisib (Piqray) 300 mg PO once per day
Endocrine 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
References
- 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 3 (C) | Alpelisib & Fulvestrant | Inferior PFS |
| Dent et al. 2020 (SANDPIPER) | 2015-2017 | Phase 3 (C) | Taselisib & Fulvestrant | Inferior PFS |
Note: patients enrolled in these trials had HR-positive breast cancer.
Endocrine 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
References
- 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
- 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
Paclitaxel monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Turner et al. 2021 (IPATunity130) | 2018-2019 | Phase 3 (C) | Ipatasertib & Paclitaxel | Did not meet primary endpoint of PFS |
Biomarker eligibility criteria
- HR+ HER2-negative PIK3CA/AKT1/PTEN-altered
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15
28-day cycles
References
- IPATunity130: Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. Epub 2021 Dec 3. link to original article contains protocol PubMed NCT03337724