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>
 
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=Guidelines=
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'''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=
 
=Advanced or metastatic disease, all lines of therapy=
 
==Alpelisib & Fulvestrant {{#subobject:a019cd|Regimen=1}}==
 
==Alpelisib & Fulvestrant {{#subobject:a019cd|Regimen=1}}==
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|-
 
|-
 
|[https://doi.org/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)]
 
|[https://doi.org/10.1056/NEJMoa1813904 André et al. 2019 (SOLAR-1)]
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|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-163-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-163-1 <span style="color:white;">ESMO-MCBS (2)</span>]'''
 
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|2015-2017
 
|2015-2017
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
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====Targeted therapy====
 
====Targeted therapy====
−
*[[Alpelisib (Piqray)]] 300 mg PO once per day
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*[[Alpelisib (Piqray)]] 300 mg PO once per day on days 1 to 28
 
====Endocrine therapy====
 
====Endocrine therapy====
 
*[[Fulvestrant (Faslodex)]] as follows:
 
*[[Fulvestrant (Faslodex)]] as follows:
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</div></div>
 
</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] [https://clinicaltrials.gov/ct2/show/NCT02437318 Clinical Trial Registry]
+
# '''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]
 
##'''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] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8210974/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33780274/ 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}}==
 
==Fulvestrant monotherapy {{#subobject:a09ggd|Regimen=1}}==
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</div></div>
 
</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] [https://clinicaltrials.gov/ct2/show/NCT02437318 Clinical Trial Registry]
+
# '''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]
 
##'''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] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8210974/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33780274/ 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]
−
# '''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] [https://pubmed.ncbi.nlm.nih.gov/33186740/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT02340221 Clinical Trial Registry]
+
# '''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}}==
 
==Paclitaxel monotherapy {{#subobject:jg71gd|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
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|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8831286/ Turner et al. 2021 (IPATunity130)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8831286/ Turner et al. 2021 (IPATunity130)]
−
|2018-2019
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|2018-01-06 to 2019-03-29
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
−
|[[#Ipatasertib_.26_Paclitaxel_777|Ipatasertib & Paclitaxel]]
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|[[#Ipatasertib_.26_Paclitaxel_999|Ipatasertib & Paclitaxel]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|-
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'''28-day cycles'''
 
'''28-day cycles'''
 
</div></div>
 
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===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://www.ncbi.nlm.nih.gov/pmc/articles/pmc8831286/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34860318/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT03337724 Clinical Trial Registry]
+
#'''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:Breast cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Malignant breast neoplasm]]
 
[[Category:Malignant breast neoplasm]]

Latest revision as of 12:17, 23 June 2024

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Section editor
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

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

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

  1. 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

  1. 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
  2. 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

28-day cycles

References

  1. 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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