Breast cancer, BRCA-mutated

Section editor transclusions

10 regimens on this page 13 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

• 2011: BRCA in breast cancer: ESMO Clinical Practice Guidelines PubMed

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

• Olaparib (Lynparza) 100 mg PO twice per day

Continued indefinitely

Variant #2, 300 mg twice per day

Study	Evidence	Comparator	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

• Olaparib (Lynparza) 300 mg PO twice per day

Continued indefinitely

Variant #3, 400 mg twice per day

Study	Evidence
Tutt et al. 2010	Phase II
Kaufman et al. 2014	Phase II

Patients in Kaufman et al. 2014 had germline BRCA1/2 mutations and had progressed after at least three lines of treatment for metastatic disease.

Chemotherapy

• Olaparib (Lynparza) 400 mg PO twice per day

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. 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

Talazoparib monotherapy

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Regimen

FDA-recommended dose

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

Chemotherapy

• Talazoparib (Talzenna) 1 mg PO once per day

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

• Breast cancer BRCA1/BRCA2 genetic testing