Breast cancer, PIK3CA-mutated

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Last updated on 2024-12-02:5 regimens on this page
5 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.
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==NCCN==
*NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Breast Cancer.
=Advanced or metastatic disease, first-line=
==Fulvestrant & Palbociclib==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Turner et al. 2024 (INAVO120)	2020-01-29 to 2023-09-14	Phase 3 (C)	Fulvestrant, Inavolisib, Palbociclib	Shorter PFSMedian PFS: 7.3 vs 15 mo(HR 2.33, 95% CI 1.69-3.12)
====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
====Targeted therapy====
*Palbociclib (Ibrance) 125 mg PO once per day on days 1 to 21
28-day cycles
===References===
# INAVO120: Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT04191499
==Fulvestrant, Inavolisib, Palbociclib==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Turner et al. 2024 (INAVO120)	2020-01-29 to 2023-09-14	Phase 3 (E-esc)	Fulvestrant & Palbociclib	Longer PFS (primary endpoint)Median PFS: 15 vs 7.3 mo(HR 0.43, 95% CI 0.32-0.59)
====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
====Targeted therapy====
*Inavolisib (Itovebi) 9 mg PO once per day on days 1 to 28
*Palbociclib (Ibrance) 125 mg PO once per day on days 1 to 21
28-day cycles
===References===
# INAVO120: Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT04191499
=Advanced or metastatic disease, all lines of therapy=
==Alpelisib & Fulvestrant==
===Regimen===
FDA-recommended dose
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
André et al. 2019 (SOLAR-1)	2015-2017 	Phase 3 (E-RT-esc)	Fulvestrant	Longer PFS1 (primary endpoint)Median PFS: 11 vs 5.7 mo(HR 0.65, 95% CI 0.50-0.85)
1Reported efficacy is for the cohort of patients with PIK3CA-mutated cancer.
Note: patients enrolled in this trial had HR-positive breast cancer.
====Targeted therapy====
*Alpelisib (Piqray) 300 mg PO once per day on days 1 to 28
====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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT02437318
##Update: André F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Pápai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. Epub 2020 Nov 25. link to original article EuroPMC
##PRO analysis: Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, André F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. Epub 2021 Mar 29. link to original article link to PMC article EuroPMC
==Fulvestrant monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
André et al. 2019 (SOLAR-1) 	2015-2017 	Phase 3 (C)	Alpelisib & Fulvestrant	Shorter PFS1Median PFS: 5.7 vs 11 mo(HR 1.54, 95% CI 1.18-2.00)
Dent et al. 2020 (SANDPIPER)	2015-2017 	Phase 3 (C)	Taselisib & Fulvestrant	Shorter PFS
1Reported efficacy for SOLAR-1 is for the cohort of patients with PIK3CA-mutated cancer.
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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT02437318
##Update: André F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Pápai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. Epub 2020 Nov 25. link to original article EuroPMC
##PRO analysis: Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, André F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. Epub 2021 Mar 29. link to original article link to PMC article EuroPMC
# 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 link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02340221
==Paclitaxel monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Turner et al. 2021 (IPATunity130)	2018-01-06 to 2019-03-29	Phase 3 (C)	Ipatasertib & Paclitaxel	Did not meet primary endpoint of PFSMedian PFS: 9.3 vs 9.3 mo(HR 1.00, 95% CI 0.71-1.41)
====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 dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT03337724
Category:Breast cancer regimens
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Category:Malignant breast neoplasm