EMBRACA
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.
Overview
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.
- Median 8.6 vs 5.6 months with Talazoparib compared with Chemotherapy; about 3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 46 percent lower chance of the event at any given time (hazard ratio 0.54, likely range 0.41 to 0.71).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- The treated group had about 15 percent lower chance of the event at any given time (hazard ratio 0.85).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer: talazoparib vs physician's choice chemotherapy. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (BRCA); the result should not be assumed for people whose cancer does not have it.
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 participants 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 | - | - |
Similar pages
not linked directly; found by shared links- TrialOlympiAD
Shares Germline BRCA mutation (gBRCA), Vinorelbine, Eribulin, Metastatic triple-negative breast cancer.
- TrialA Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
- TrialStudy of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
- TrialAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
- TreatmentBRACAnalysis CDx
Shares Germline BRCA mutation (gBRCA), Talazoparib, PARP, BRCA1 / BRCA2 (HRD).
- TrialA Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment o
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
- TrialASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Shares Vinorelbine, Eribulin, Capecitabine, Gemcitabine.
- TreatmentIniparib
Shares Talazoparib, PARP inhibitors, PARP, Triple-negative breast cancer (TNBC).