Difference between revisions of "Breast cancer, PIK3CA-mutated"
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<big>'''Note: this page has regimens which are specific to breast cancer that is PIK3CA-mutated. Please see the [[Breast cancer|main breast cancer]] page for other chemotherapy regimens.'''</big> | <big>'''Note: this page has regimens which are specific to breast cancer that is PIK3CA-mutated. Please see the [[Breast cancer|main breast cancer]] page for other chemotherapy regimens.'''</big> | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
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=Advanced or metastatic disease, all lines of therapy= | =Advanced or metastatic disease, all lines of therapy= | ||
==Alpelisib & Fulvestrant {{#subobject:a019cd|Regimen=1}}== | ==Alpelisib & Fulvestrant {{#subobject:a019cd|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:31ed8c|Variant=1}}=== | ===Regimen {{#subobject:31ed8c|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
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''<sup>1</sup>Reported efficacy is for the cohort of patients with PIK3CA-mutated cancer.''<br> | ''<sup>1</sup>Reported efficacy is for the cohort of patients with PIK3CA-mutated cancer.''<br> | ||
''Note: patients enrolled in this trial had HR-positive breast cancer.'' | ''Note: patients enrolled in this trial had HR-positive breast cancer.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Alpelisib (Piqray)]] 300 mg PO once per day | *[[Alpelisib (Piqray)]] 300 mg PO once per day | ||
− | |||
====Endocrine therapy==== | ====Endocrine therapy==== | ||
*[[Fulvestrant (Faslodex)]] as follows: | *[[Fulvestrant (Faslodex)]] as follows: | ||
**Cycle 1: 500 mg IM once per day on days 1 & 15 | **Cycle 1: 500 mg IM once per day on days 1 & 15 | ||
**Cycle 2 onwards: 500 mg IM once on day 1 | **Cycle 2 onwards: 500 mg IM once on day 1 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1056/NEJMoa1813904 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31091374 PubMed] NCT02437318 | # '''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. [https://doi.org/10.1056/NEJMoa1813904 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31091374 PubMed] 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. [https://doi.org/10.1016/j.annonc.2020.11.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33246021/ PubMed] | ##'''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. [https://doi.org/10.1016/j.annonc.2020.11.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33246021/ PubMed] | ||
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==Fulvestrant monotherapy {{#subobject:a09ggd|Regimen=1}}== | ==Fulvestrant monotherapy {{#subobject:a09ggd|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:18ut8c|Variant=1}}=== | ===Regimen {{#subobject:18ut8c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 74: | Line 71: | ||
|} | |} | ||
''Note: patients enrolled in these trials had HR-positive breast cancer.'' | ''Note: patients enrolled in these trials had HR-positive breast cancer.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Endocrine therapy==== | ====Endocrine therapy==== | ||
*[[Fulvestrant (Faslodex)]] as follows: | *[[Fulvestrant (Faslodex)]] as follows: | ||
**Cycle 1: 500 mg IM once per day on days 1 & 15 | **Cycle 1: 500 mg IM once per day on days 1 & 15 | ||
**Cycle 2 onwards: 500 mg IM once on day 1 | **Cycle 2 onwards: 500 mg IM once on day 1 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1056/NEJMoa1813904 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31091374 PubMed] NCT02437318 | # '''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. [https://doi.org/10.1056/NEJMoa1813904 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31091374 PubMed] 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. [https://doi.org/10.1016/j.annonc.2020.11.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33246021/ PubMed] | ##'''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. [https://doi.org/10.1016/j.annonc.2020.11.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33246021/ PubMed] | ||
# '''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. [https://doi.org/10.1016/j.annonc.2020.10.596 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33186740/ PubMed] NCT02340221 | # '''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. [https://doi.org/10.1016/j.annonc.2020.10.596 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33186740/ PubMed] NCT02340221 | ||
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==Paclitaxel monotherapy {{#subobject:jg71gd|Regimen=1}}== | ==Paclitaxel monotherapy {{#subobject:jg71gd|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:gjz18c|Variant=1}}=== | ===Regimen {{#subobject:gjz18c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 103: | Line 99: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*HR+ HER2-negative PIK3CA/AKT1/PTEN-altered | *HR+ HER2-negative PIK3CA/AKT1/PTEN-altered | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | *[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1007/s10549-021-06450-x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34860318/ PubMed] NCT03337724 | #'''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. [https://doi.org/10.1007/s10549-021-06450-x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34860318/ PubMed] NCT03337724 | ||
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[[Category:Breast cancer regimens]] | [[Category:Breast cancer regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Malignant breast neoplasm]] | [[Category:Malignant breast neoplasm]] |
Revision as of 14:59, 18 February 2023
3 regimens on this page
3 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
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 PFS1 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
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 dosing details in manuscript PubMed 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 PubMed
Fulvestrant monotherapy
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 dosing details in manuscript PubMed 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 PubMed
- 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
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
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 dosing details in abstract PubMed NCT03337724