Breast cancer, BRCA-mutated

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Hermina Fernandes, MD, FACP
University of North Dakota
Bismarck, ND
2 regimens on this page
4 variants on this page

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

ESMO

Advanced or metastatic disease, all lines of therapy

Olaparib monotherapy

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Variant #1, 100 mg twice per day

Study Evidence
Tutt et al. 2010 Phase II

Chemotherapy

Continued indefinitely

Variant #2, 300 mg twice per day

Study Evidence Comparator Comparative Efficacy
Robson et al. 2017 (OlympiAD) Phase III (E) 1. Capecitabine
2. Eribulin
3. Vinorelbine
Superior PFS

Patients had confirmed deleterious or suspected deleterious germline BRCA mutation. This is the FDA-approved dose.

Chemotherapy

Continued indefinitely

Variant #3, 400 mg twice per day

Study Evidence
Tutt et al. 2010 Phase II
Kaufman et al. 2014 (Study 42) Phase II

Patients in Study 42 had germline BRCA1/2 mutations and had progressed after at least three lines of treatment for metastatic disease.

Chemotherapy

Continued indefinitely

References

  1. 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
  2. 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 verified protocol PubMed
  3. 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 verified protocol PubMed
    1. 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

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Regimen

FDA-recommended dose
Study Evidence Comparator Comparative Efficacy
Litton et al. 2018 (EMBRACA) Phase III (E-RT) Physician's choice of:
1. Capecitabine
2. Eribulin
3. Gemcitabine
4. Vinorelbine
Superior PFS

Chemotherapy

Continued indefinitely

References

  1. 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 protocol PubMed

Additional resources

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