Preoperative combination of gemcitabine, carboplatin, and iniparib is active in the treatment of patients with early-stage triple negative and BRCA1/2 mutation-associated breast cancer, a new study published online early in the Journal of Clinical Oncology has shown.

For the single-arm phase II study, researchers sought to assess the safety, efficacy, and predictors of response to the combination of gemcitabine, carboplatin, and iniparib in patients with early-stage triple-negative andBRCA1/2 mutation-associated breast cancer.

Researchers identified 80 patients, 24% of which had germline BRCA1 or BRCA2 mutations. Patients received neoadjuvant gemcitabine 1,000mg/m2 IV and carboplatin AUC 2 IV on days 1 and 8 plus iniparib 5.6mg/kg IV on days 1, 4, 8, and 11 for six 21-day cycles.

Continue Reading

Results showed that the overall pathologic complettte response rate was 36% (90% CI: 27-46). 

Researchers found that mean LRD-LOH scores were higher in responders compared with nonresponders (P = 0.02).

RELATED: Tumor DNA Repair Function Could Identify Patients That May Benefit from Platinum Agents

When BRCA1/2 germline mutation carriers were excluded, the mean HRD-LOH scores continued to be significantly higher in responders versus nonresponders (= 0.021).

The authors note that confirmatory controlled trials are warranted.

Preliminary findings were presented at the 49th Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois, in 2013.


  1. Telli ML, Jensen KC, Vinayak S, et al. Phase II study of gemcitabine, carboplatin, and iniparib as neoadjuvant therapy for triple-negative and BRCA1/2 mutation-associated breast cancer with assessment of a tumor-based measure of genomic instability: PrECOG 0105. J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1200/JCO.2014.57.0085.