drugset / Trial / NCT02546934
ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
RandomizedParallel-groupOpen-labelTreatment
Summary
ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
Timeline
- Start
- 2016-03
- Primary completion
- 2020-04
- Completion
- 2020-04
Outcome
Met primary endpoint
paper The median PFS is 9.8 months with AP as compared to 7.4 months with GP (stratified HR, 0.67; 95% CI, 0.50-0.88; P = 0.004). PMID 35821019 ↗
paper The trial has met pre-specified endpoints. PMID 35821019 ↗
Publications
- Wang B, Sun T, Zhao Y, Wang S, Zhang J, Wang Z, Teng YE, Cai L, Yan M, Wang X, Jiang Z, Pan Y, Luo J, Shao Z, Wu J, Guo X, Hu X. A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022 Jul 12;13(1):4025. doi: 10.1038/s41467-022-31704-7.
- Wang B, Zhao Y, Li Y, Xu Y, Chen Y, Jiang Q, Yao D, Zhang L, Hu X, Fu C, Zhang S, Chen S. A plasma SNORD33 signature predicts platinum benefit in metastatic triple-negative breast cancer patients. Mol Cancer. 2022 Jan 18;21(1):22. doi: 10.1186/s12943-022-01504-0. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |