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	TBA

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.

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, 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	Superior 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 contains dosing details in manuscript PubMed NCT02437318
1. 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
2. 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 PubMed

Fulvestrant monotherapy

Regimen

Study	Dates 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
1. 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
2. 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 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 link to PMC article contains dosing details in manuscript PubMed 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 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 dosing details in abstract link to PMC article PubMed NCT03337724

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+<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
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+{{#lst:Editorial board transclusions|breast}}
 {| class="wikitable" style="float:right; margin-right: 5px;"
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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>
 {{TOC limit|limit=3}}
+=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 [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419 NCCN Guidelines - Breast Cancer].''
 =Advanced or metastatic disease, all lines of therapy=
 ==Alpelisib & Fulvestrant {{#subobject:a019cd|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:31ed8c|Variant=1}}===
 {| class="wikitable" style="color:white; background-color:#404040"
@@ Line 18: / Line 25: @@
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
@@ Line 24: / Line 31: @@
 |-
 |[https://doi.org/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)]
+<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
+|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-163-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
+|-
+|} -->
 |2015-2017
 | style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 |[[#Fulvestrant_monotherapy|Fulvestrant]]
-| style="background-color:#1a9850" |Superior PFS<sup>1</sup><br>Median PFS: 11 vs 5.7 mo<br>(HR 0.65, 95% CI 0.50-0.85)
+| style="background-color:#1a9850" |Superior PFS<sup>1</sup> (primary endpoint)<br>Median PFS: 11 vs 5.7 mo<br>(HR 0.65, 95% CI 0.50-0.85)
 |-
 |}
 ''<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.''
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Targeted therapy====
-*[[Alpelisib (Piqray)]] 300 mg PO once per day
+*[[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'''
+</div></div>
 ===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] [https://clinicaltrials.gov/study/NCT02437318 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]
+##'''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. [https://doi.org/10.1200/jco.20.01139 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8210974/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33780274/ PubMed]
 ==Fulvestrant monotherapy {{#subobject:a09ggd|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:18ut8c|Variant=1}}===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
@@ Line 62: / Line 73: @@
 | style="background-color:#d73027" |Inferior PFS
 |-
-|[https://doi.org/10.1016/j.annonc.2020.10.596 Dent et al. 2020 (SANDPIPER)]
+|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8457522/ Dent et al. 2020 (SANDPIPER)]
 |2015-2017
 | style="background-color:#1a9851" |Phase 3 (C)
-|[[#Taselisib_.26_Fulvestrant_77|Taselisib & Fulvestrant]]
+|[[#Taselisib_.26_Fulvestrant_777|Taselisib & Fulvestrant]]
 | style="background-color:#d73027" |Inferior PFS
 |-
 |}
 ''Note: patients enrolled in these trials had HR-positive breast cancer.''
+<div class="toccolours" style="background-color:#b3e2cd">
 ====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'''
+</div></div>
 ===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] [https://clinicaltrials.gov/study/NCT02437318 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]
-# '''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
+##'''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. [https://doi.org/10.1200/jco.20.01139 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8210974/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33780274/ 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://www.ncbi.nlm.nih.gov/pmc/articles/pmc8457522/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/33186740/ PubMed] [https://clinicaltrials.gov/study/NCT02340221 NCT02340221]
 ==Paclitaxel monotherapy {{#subobject:jg71gd|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:gjz18c|Variant=1}}===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
 !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 |-
-|[https://doi.org/10.1007/s10549-021-06450-x Turner et al. 2021 (IPATunity130)]
+|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8831286/ Turner et al. 2021 (IPATunity130)]
-|2018-2019
+|2018-01-06 to 2019-03-29
 | style="background-color:#1a9851" |Phase 3 (C)
-|[[#Ipatasertib_.26_Paclitaxel_77|Ipatasertib & Paclitaxel]]
+|[[#Ipatasertib_.26_Paclitaxel_999|Ipatasertib & Paclitaxel]]
 | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 |-
 |}
+<div class="toccolours" style="background-color:#fdcdac">
 ====Biomarker eligibility criteria====
 *HR+ HER2-negative PIK3CA/AKT1/PTEN-altered
+</div>
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Chemotherapy====
 *[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 '''28-day cycles'''
+</div></div>
 ===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://www.ncbi.nlm.nih.gov/pmc/articles/pmc8831286/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34860318/ PubMed] [https://clinicaltrials.gov/study/NCT03337724 NCT03337724]
 [[Category:Breast cancer regimens]]
 [[Category:Biomarker-specific pages]]
 [[Category:Malignant breast neoplasm]]

Difference between revisions of "Breast cancer, PIK3CA-mutated"

Latest revision as of 12:17, 23 June 2024

Contents

Guidelines

NCCN

Advanced or metastatic disease, all lines of therapy

Alpelisib & Fulvestrant

Regimen

Targeted therapy

Endocrine therapy

References

Fulvestrant monotherapy

Regimen

Endocrine therapy

References

Paclitaxel monotherapy

Regimen

Biomarker eligibility criteria

Chemotherapy

References

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