# BROCADE3

Source: https://onco.cc/trials/brocade3/  
OnCo record `brocade3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

BROCADE3 added the PARP inhibitor veliparib to carboplatin and paclitaxel for advanced breast cancer in women with an inherited BRCA mutation. It delayed progression by about two months but did not lengthen life, and the drug was never licensed; the long survival on chemotherapy alone showed how active platinum is in this group.

## Summary

BROCADE3 (NCT02163694) randomised 513 patients (509 in the intention-to-treat population with a centrally confirmed germline BRCA mutation; 337 veliparib, 172 placebo) between July 2014 and January 2018 to carboplatin AUC 6 on day 1 and paclitaxel 80 mg/m2 on days 1, 8 and 15 of 21 with veliparib 120 mg or placebo twice daily on days minus 2 to 5, continued at an intensified dose as monotherapy if chemotherapy stopped before progression; the control group could cross over to veliparib on progression. Median progression-free survival was 14.5 versus 12.6 months (hazard ratio 0.71, 95 percent confidence interval 0.57 to 0.88, p 0.0016). Final overall survival (European Journal of Cancer 2024) was 32.4 versus 28.2 months (hazard ratio 0.916, 0.736 to 1.140, p 0.434). Grade 3 or worse neutropenia occurred in 81 versus 84 percent, anaemia 42 versus 40 percent and thrombocytopenia 40 versus 28 percent. The trial matters for triple-negative disease because roughly half of germline BRCA breast cancers are triple-negative and because it is the only phase 3 of a PARP inhibitor given with, rather than instead of, chemotherapy: the progression-free survival gain did not become a survival gain, and the 28-month median survival of the carboplatin and paclitaxel control arm is the benchmark for platinum doublets in BRCA-mutated disease. AbbVie did not seek approval. UK sites (registry, 4): Bristol, Hull, Nottingham, University Hospitals Birmingham.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-24
- Registry id: NCT02163694
- Phase: 3
- Setting: Germline BRCA1 or BRCA2-mutated HER2-negative metastatic or locally advanced unresectable breast cancer, up to two prior chemotherapy lines: carboplatin and paclitaxel with veliparib or placebo, continued as veliparib monotherapy if chemotherapy stopped, 147 hospitals in 36 countries
- Sponsor: AbbVie
- Enrolled: 513
- Result: PFS 14.5 vs 12.6 months (HR 0.71, p 0.0016); final OS 32.4 vs 28.2 months (HR 0.92, p 0.43). Not licensed.
- Outcomes: Progression-free survival (investigator): Veliparib + carboplatin + paclitaxel 14.5 months vs Placebo + carboplatin + paclitaxel 12.6 months, HR 0.71; Overall survival (final): Veliparib + carboplatin + paclitaxel 32.4 months vs Placebo + carboplatin + paclitaxel 28.2 months, HR 0.916
- Replication: OlympiAD and EMBRACA (PARP inhibitor instead of chemotherapy) also improved progression-free but not overall survival in germline BRCA breast cancer.

## Notes

- UK sites (registry, 4): University Hospitals Bristol, Hull University Teaching Hospitals, Nottingham University Hospitals, University Hospitals Birmingham.

## Sources

- ClinicalTrials.gov NCT02163694: https://clinicaltrials.gov/study/NCT02163694
- Dieras et al., Lancet Oncology 2020: veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): https://doi.org/10.1016/S1470-2045(20)30447-2
- BROCADE3 final overall survival (European Journal of Cancer 2024): https://doi.org/10.1016/j.ejca.2024.113580

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [PARP](https://onco.cc/targets/parp/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Veliparib](https://onco.cc/drugs/veliparib/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/)
- terms: [Germline BRCA mutation (gBRCA)](https://onco.cc/terms/gbrca-mutation/)
- trials: [BrighTNess](https://onco.cc/trials/brightness/), [EMBRACA](https://onco.cc/trials/embraca/), [OlympiAD](https://onco.cc/trials/olympiad/), [TNT (Triple Negative Trial)](https://onco.cc/trials/tnt/)

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