Difference between revisions of "Breast cancer, PIK3CA-mutated"
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Warner-admin (talk | contribs) m (Text replacement - "====Hormonotherapy====" to "====Endocrine therapy====") |
m (Text replacement - "style="background-color:#1a9851" |Phase III" to "style="background-color:#1a9851" |Phase 3") |
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|[https://www.nejm.org/doi/full/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)] | |[https://www.nejm.org/doi/full/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)] | ||
|2015-2017 | |2015-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) |
|[[#Fulvestrant_monotherapy|Fulvestrant]] | |[[#Fulvestrant_monotherapy|Fulvestrant]] | ||
| style="background-color:#1a9850" |Superior PFS | | style="background-color:#1a9850" |Superior PFS | ||
| Line 62: | Line 62: | ||
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)] | |[https://www.nejm.org/doi/full/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)] | ||
|2015-2017 | |2015-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Alpelisib_.26_Fulvestrant|Alpelisib & Fulvestrant]] | |[[#Alpelisib_.26_Fulvestrant|Alpelisib & Fulvestrant]] | ||
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS | ||
| Line 68: | Line 68: | ||
|[https://doi.org/10.1016/j.annonc.2020.10.596 Dent et al. 2020 (SANDPIPER)] | |[https://doi.org/10.1016/j.annonc.2020.10.596 Dent et al. 2020 (SANDPIPER)] | ||
|2015-2017 | |2015-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|Taselisib & Fulvestrant | |Taselisib & Fulvestrant | ||
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS | ||
Revision as of 02:36, 16 December 2021
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
| back to top |
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
| back to top |
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