gBRCA Testing and Treatment Guidelines

Identifying Patients for gBRCA Testing

Test patients with HER2- LABC or mBC for gBRCA mutations to inform treatment planning2
  • Patients with gBRCA mutations are significantly more likely to develop breast cancer and at younger ages than the general population3
  • Patients with gBRCA HER2- mBC have limited effective treatment options, with 4-year real-world OS rate <36%4
Mutations in gBRCA may be present in many types of patients3,4*
Not all have a family history of breast cancer
Not all have triple-negative disease
Not all are young
Not all are white
Not all are women

*According to a retrospective real-world analysis of clinical outcomes, treatment patterns, and health resource utilization among 229 HER2- gBRCA1/2-mutated mBC patients diagnosed between January 2011 and February 2018.4




Clinical Guidelines Recommend Early gBRCA Testing for Therapeutic Considerations

5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)5:







BRCA=breast cancer susceptibility gene; CI=confidence interval; ESMO=European Society for Medical Oncology; ESO=European School of Oncology; ET=endocrine therapy; gBRCA=germline breast cancer susceptibility gene; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; LABC=locally advanced breast cancer; mBC=metastatic breast cancer; OS=overall survival; PARPis=poly (ADP-ribose) polymerase inhibitors; PFS=progression-free survival; QoL=quality of life; TNBC=triple-negative breast cancer.



  1. TALZENNA Summary of Product Characteristics.
  2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 2022. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  3. Kuchenbaecker KB, Hopper JL, Barnes DR, et al; and the BRCA1 and BRCA2 Cohort Consortium. Risks of breast, ovarian, and contralateral breast cancer for BRCA1 and BRCA2 mutation carriers. JAMA. 2017;317(23):2402-2416. doi:10.1001/jama.2017.7112.
  4. Quek RGW, Mardekian J. Clinical outcomes, treatment patterns, and health resource utilization among metastatic breast cancer patients with germline BRCA1/2 mutation: a real-world retrospective study. Adv Ther. 2019;36(3):708-720.
  5. Cardoso F, Senkus E, Costa A, et al. 5th ESO-ESMO Interantional Consensus Guidelines for Advanced Breast Cancer (ABC 5). Ann Oncol. 2020;31(12):1623-1649.
  6. Gavande NS, VanderVere-Carozza PS, Hinshaw HD, et al. DNA repair targeted therapy: the past or future of cancer treatment? Pharmacol Ther. 2016;160:65-83.
  7. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.
  8. Hurvitz SA, Gonçalvez A, Rugo HS, et al. Talazoparib, an oral poly(ADP-ribose) polymerase inhibitor for patients with locally advanced/metastatic breast cancer and a germline BRCA mutation: detailed safety analyses from the randomized, multinational, phase 3 EMBRACA trial. Poster presented at: 36th Annual Miami Breast Cancer Conference; March 7-10, 2019; Miami, FL. Poster 761.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.