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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
431 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Talazoparib | 287 | 8.6 months | 0.54 (0.41 to 0.71) | <0.001 | link |
| Chemotherapy | 144 | 5.6 months | ||||
| Overall survival (final) | Talazoparib | - | - | 0.85 (0.67 to 1.07) | - | link |
| Chemotherapy | - | - |
The document that made immunotherapy, PARP inhibition and the first antibody-drug conjugate the European standard for metastatic triple-negative disease; every later first-line change is an amendment to it.
Sets the surgical and systemic rules for the one in nine to one in six triple-negative patients who carry a germline BRCA variant (11 to 17 percent by cohort); the adjuvant gap it named was filled by OlympiA the following year.
This is the paper Europe PMC returns for registry id NCT01945775 with the most citations, so it is the natural first reading for anyone following the EMBRACA trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer, BROCADE3, Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline, BRCA-associated triple-negative breast cancer.
Shares BROCADE3, PARP, PARP inhibitors, BRCA1 / BRCA2 (HRD).
Shares Vinorelbine, Eribulin, Metastatic triple-negative breast cancer, Capecitabine.
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
Shares Talazoparib, Germline BRCA mutation (gBRCA), PARP, BRCA1 / BRCA2 (HRD).
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
Shares Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline, BRCA-associated triple-negative breast cancer, Germline BRCA mutation (gBRCA), PARP inhibitors.