Breast cancer, BRCA-mutated
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Section editor | |
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H. Deepika Fernandes, MD, FACP Virginia G. Piper Cancer Care Network Comprehensive Breast Center of Arizona Scottsdale, AZ |
10 regimens on this page
13 variants on this page
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Note: this page has regimens which are specific to breast cancer that is BRCA-mutated. Please see the main breast cancer page for other chemotherapy regimens.
Guidelines
ASCO
- 2021: Tung et al. Adjuvant PARP Inhibitors in Patients With High-Risk Early-Stage HER2-Negative Breast Cancer and Germline BRCA Mutations: ASCO Hereditary Breast Cancer Guideline Rapid Recommendation Update PubMed
ESMO
- 2011: Balmaña et al. BRCA in breast cancer: ESMO Clinical Practice Guidelines PubMed
Adjuvant therapy
Olaparib monotherapy
Regimen
FDA-recommended dose |
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | |
---|---|---|---|---|---|
Tutt et al. 2021 (OlympiA)
|
2014-2019 | Phase 3 (E-RT-esc) | Placebo | Superior OS1 (secondary endpoint) OS48: 89.8% vs 86.4% (HR 0.68, 98.5% CI 0.47-0.97) |
1Reported efficacy is based on the 2022 update.
Preceding treatment
- Primary local treatment +/- (neo-)adjuvant therapy
References
- OlympiA: Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmaña J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. Epub 2021 Jun 3. link to original article contains dosing details in manuscript link to PMC article PubMed Clinical Trial Registry
- Update: Geyer CE Jr, Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, Rastogi P, Cui K, Arahmani A, Aktan G, Armstrong AC, Arnedos M, Balmaña J, Bergh J, Bliss J, Delaloge S, Domchek SM, Eisen A, Elsafy F, Fein LE, Fielding A, Ford JM, Friedman S, Gelmon KA, Gianni L, Gnant M, Hollingsworth SJ, Im SA, Jager A, Jóhannsson ÓÞ, Lakhani SR, Janni W, Linderholm B, Liu TW, Loman N, Korde L, Loibl S, Lucas PC, Marmé F, Martinez de Dueñas E, McConnell R, Phillips KA, Piccart M, Rossi G, Schmutzler R, Senkus E, Shao Z, Sharma P, Singer CF, Španić T, Stickeler E, Toi M, Traina TA, Viale G, Zoppoli G, Park YH, Yerushalmi R, Yang H, Pang D, Jung KH, Mailliez A, Fan Z, Tennevet I, Zhang J, Nagy T, Sonke GS, Sun Q, Parton M, Colleoni MA, Schmidt M, Brufsky AM, Razaq W, Kaufman B, Cameron D, Campbell C, Tutt ANJ; OlympiA Clinical Trial Steering Committee and Investigators. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022 Dec 1;33(12):1250-1268. Epub 2022 Oct 10. link to original article PubMed
Advanced or metastatic disease, subsequent lines of therapy
Capecitabine monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Litton et al. 2018 (EMBRACA) | 2013-10 to 2017-04 | Phase 3 (C) | Talazoparib | Inferior PFS |
Robson et al. 2017 (OlympiAD) | 2014-04-07 to 2015-11-27 | Phase 3 (C) | Olaparib | Inferior PFS |
Biomarker eligibility criteria
- EMBRACA: Germline BRCA1 or BRCA2 mutation
- OlympiAD: Confirmed deleterious or suspected deleterious germline BRCA mutation
References
- OlympiAD: Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. link to original article contains dosing details in manuscript PubMed Clinical Trial Registry
- Update: Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. link to original article link to PMC article PubMed
- EMBRACA: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. link to original article contains dosing details in supplement PubMed Clinical Trial Registry
- PRO analysis: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Gonçalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. link to original article PubMed
- Update: Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. link to original article PubMed
Carboplatin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tutt et al. 2018 (TNT) | 2008-2014 | Phase 3 (E-switch-ic) | Docetaxel | Superior ORR1 |
1Reported efficacy is based on subgroup analysis.
References
- TNT: Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. Epub 2018 Apr 30. link to original article link to PMC article contains dosing details in manuscript PubMed Clinical Trial Registry
Carboplatin & Paclitaxel (CP)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Diéras et al. 2020 (BROCADE3) | 2014-2018 | Phase 3 (C) | CP & Veliparib | Inferior PFS |
Biomarker eligibility criteria
- Confirmed deleterious germline BRCA1 or BRCA2 mutation
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV once on day 1
- Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15
21-day cycles
References
- BROCADE3: Diéras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palácová M, Park YH, Shparyk Y, Yañez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. Epub 2020 Aug 27. link to original article contains dosing details in manuscript PubMed Clinical Trial Registry
Docetaxel monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tutt et al. 2018 (TNT) | 2008-2014 | Phase 3 (C) | Carboplatin | Inferior ORR1 |
1Reported efficacy is based on subgroup analysis.
References
- TNT: Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. Epub 2018 Apr 30. link to original article link to PMC article contains dosing details in manuscript PubMed Clinical Trial Registry
Eribulin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Litton et al. 2018 (EMBRACA) | 2013-10 to 2017-04 | Phase 3 (C) | Talazoparib | Inferior PFS |
Robson et al. 2017 (OlympiAD) | 2014-04-07 to 2015-11-27 | Phase 3 (C) | Olaparib | Inferior PFS |
Biomarker eligibility criteria
- EMBRACA: Germline BRCA1 or BRCA2 mutation
- OlympiAD: Confirmed deleterious or suspected deleterious germline BRCA mutation
Chemotherapy
- Eribulin (Halaven) 1.4 mg/m2 IV over 2 to 5 minutes once per day on days 1 & 8
21-day cycles
References
- OlympiAD: Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. link to original article contains dosing details in manuscript PubMed Clinical Trial Registry
- Update: Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. link to original article link to PMC article PubMed
- EMBRACA: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. link to original article contains dosing details in supplement PubMed Clinical Trial Registry
- PRO analysis: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Gonçalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. link to original article PubMed
- Update: Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. link to original article PubMed
Gemcitabine monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Litton et al. 2018 (EMBRACA) | 2013-10 to 2017-04 | Phase 3 (C) | Talazoparib | Inferior PFS |
Biomarker eligibility criteria
- Germline BRCA1 or BRCA2 mutation
Chemotherapy
- Gemcitabine (Gemzar) 1250 mg/m2 IV over 30 minutes once per day on days 1 & 8
21-day cycles
References
- EMBRACA: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. link to original article contains dosing details in supplement PubMed Clinical Trial Registry
- PRO analysis: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Gonçalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. link to original article PubMed
- Update: Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. link to original article PubMed
Olaparib monotherapy
Regimen variant #1, 100 mg twice per day
Study | Dates of enrollment | Evidence |
---|---|---|
Tutt et al. 2010 (KU36-44) | 2007-2008 | Phase 2 |
Regimen variant #2, 300 mg twice per day
FDA-recommended dose |
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | |
---|---|---|---|---|---|
Robson et al. 2017 (OlympiAD)
|
2014-04-07 to 2015-11-27 | Phase 3 (E-RT-switch-ooc) | 1a. Capecitabine 1b. Eribulin 1c. Vinorelbine |
Superior PFS (primary endpoint) Median PFS: 7.0 mo vs 4.2 mo (HR 0.58, 95% CI 0.43-0.80) Did not meet secondary endpoint of OS1 Median OS: 19.3 vs 17.1 mo (HR 0.90, 95% CI 0.66-1.23) |
1Reported efficacy for OS is based on the 2019 update.
Biomarker eligibility criteria
- Confirmed deleterious or suspected deleterious germline BRCA mutation
Regimen variant #3, 400 mg twice per day
Study | Dates of enrollment | Evidence |
---|---|---|
Tutt et al. 2010 (KU36-44) | 2007-2008 | Phase 2 |
Kaufman et al. 2014 (Study 42) | 2010-2012 | Phase 2 |
Biomarker eligibility criteria
- Study 42: Germline BRCA1/2 mutations
Prior treatment criteria
- Study 42: Progression after at least three lines of treatment for metastatic disease.
References
- KU36-44: Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, Arun B, Loman N, Schmutzler RK, Wardley A, Mitchell G, Earl H, Wickens M, Carmichael J. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):235-44. Epub 2010 Jul 6. link to original article PubMed Clinical Trial Registry
- Study 42: Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. Epub 2014 Nov 3. link to original article contains dosing details in manuscript link to PMC article PubMed Clinical Trial Registry
- OlympiAD: Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. link to original article contains dosing details in manuscript PubMed Clinical Trial Registry
- Update: Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. link to original article link to PMC article PubMed
Talazoparib monotherapy
Regimen
FDA-recommended dose |
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | |
---|---|---|---|---|---|
Turner et al. 2018 (ABRAZO) | 2014-05 to 2016-02 | Phase 2 | |||
Litton et al. 2018 (EMBRACA)
|
2013-10 to 2017-04 | Phase 3 (E-RT-switch-ooc) | Physician's choice of: 1a. Capecitabine 1b. Eribulin 1c. Gemcitabine 1d. Vinorelbine |
Superior PFS (primary endpoint) Median PFS: 8.6 vs 5.6 mo (HR 0.54, 95% CI 0.41-0.71) Did not meet secondary endpoint of OS1 Median OS: 19.3 vs 19.5 mo (HR 0.85, 95% CI 0.67-1.07) |
1Reported efficacy for OS is based on the 2020 update.
Biomarker eligibility criteria
- Germline BRCA1 or BRCA2 mutation
References
- ABRAZO: Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmaña J, Fasching PA, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME; ABRAZO Study Group. A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clin Cancer Res. 2019 May 1;25(9):2717-2724. Epub 2018 Dec 18. link to original article contains dosing details in abstract PubMed Clinical Trial Registry
- EMBRACA: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. link to original article contains dosing details in abstract PubMed Clinical Trial Registry
- PRO analysis: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Gonçalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. link to original article PubMed
- Update: Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. link to original article PubMed
Vinorelbine monotherapy
Regimen variant #1, 2 out of 3 weeks
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Robson et al. 2017 (OlympiAD) | 2014-04-07 to 2015-11-27 | Phase 3 (C) | Olaparib | Inferior PFS |
Biomarker eligibility criteria
- Confirmed deleterious or suspected deleterious germline BRCA mutation
Regimen variant #2, weekly
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Litton et al. 2018 (EMBRACA) | 2013-10 to 2017-04 | Phase 3 (C) | Talazoparib | Inferior PFS |
Biomarker eligibility criteria
- Germline BRCA1 or BRCA2 mutation
Chemotherapy
- Vinorelbine (Navelbine) 30 mg/m2 IV over 6 to 10 minutes once per day on days 1, 8, 15
21-day cycles
References
- OlympiAD: Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. link to original article contains dosing details in manuscript PubMed Clinical Trial Registry
- Update: Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. link to original article link to PMC article PubMed
- EMBRACA: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. link to original article contains dosing details in supplement PubMed Clinical Trial Registry
- PRO analysis: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Gonçalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. link to original article PubMed
- Update: Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. link to original article PubMed