# EMBRACA

Source: https://onco.cc/trials/embraca/  
OnCo record `embraca` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

EMBRACA showed that the PARP inhibitor talazoparib delays progression by about three months compared with chemotherapy in women with an inherited BRCA mutation and advanced breast cancer, with better quality of life but no gain in overall survival.

## Summary

EMBRACA, trial NCT01945775 sponsored by Pfizer through Medivation and published in the New England Journal of Medicine in 2018, randomised 431 patients with a germline BRCA1 or BRCA2 mutation and HER2-negative advanced breast cancer to talazoparib once daily or the physician's choice of capecitabine, eribulin, gemcitabine or vinorelbine. Progression-free survival rose from 5.6 to 8.6 months (hazard ratio 0.54), the response rate more than doubled and patient-reported quality of life deteriorated later on talazoparib, while anaemia needing transfusion was more common. The final overall survival analysis in 2020 showed no significant difference (hazard ratio 0.85), which the authors attributed partly to later PARP inhibitor and platinum use in the control arm. It led to the October 2018 approval of talazoparib and, with OlympiAD, established PARP inhibitors as an alternative to chemotherapy in BRCA carriers. Whether combining PARP inhibition with immunotherapy or antibody-drug conjugates adds to it is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT01945775
- Phase: 3
- Setting: Germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer: talazoparib vs physician's choice chemotherapy
- Sponsor: Pfizer (Medivation)
- Enrolled: 431
- Result: PFS 8.6 vs 5.6 months, HR 0.54; OS HR 0.85, not significant.
- Outcomes: Progression-free survival: Talazoparib 8.6 months vs Chemotherapy 5.6 months, HR 0.54; Overall survival (final): Talazoparib vs Chemotherapy, HR 0.85
- Replication: Consistent with OlympiAD; neither PARP inhibitor trial showed an overall survival gain.

## Notes

- Triple-negative disease was 44 percent of EMBRACA and a stratification factor (Talzenna label). Final overall survival (Annals of Oncology 2020): hazard ratio 0.85, medians 19.3 versus 19.5 months; 46.3 versus 41.7 percent later received platinum and 4.5 versus 32.6 percent a PARP inhibitor. Six UK sites. England: NICE TA952 (21 February 2024).

## Sources

- ClinicalTrials.gov NCT01945775: https://clinicaltrials.gov/study/NCT01945775
- Litton et al., EMBRACA (NEJM 2018): https://doi.org/10.1056/NEJMoa1802905
- NICE TA952 (21 February 2024): https://www.nice.org.uk/guidance/ta952
- Talzenna label (openFDA): EMBRACA study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TALZENNA%22

## Connected records

- cancers: [BRCA-associated triple-negative breast cancer](https://onco.cc/cancers/brca-associated-tnbc/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [PARP](https://onco.cc/targets/parp/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Eribulin](https://onco.cc/drugs/eribulin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Talazoparib](https://onco.cc/drugs/talazoparib/), [Vinorelbine](https://onco.cc/drugs/vinorelbine/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [Germline BRCA mutation (gBRCA)](https://onco.cc/terms/gbrca-mutation/)
- people: [Jennifer K. Litton](https://onco.cc/people/jennifer-litton/)
- key papers: [ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer](https://onco.cc/key-papers/paper-esmo-metastatic-breast-cancer-guideline-ann-oncol-2021/), [Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline](https://onco.cc/key-papers/paper-asco-hereditary-breast-cancer-guideline-jco-2020/), [Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation](https://onco.cc/key-papers/paper-embraca-n-engl-j-med-2018/)
- roadmaps: [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- trials: [BROCADE3](https://onco.cc/trials/brocade3/)

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