drugset / Trial / NCT01287624
Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Paclitaxel in Triple Negative Breast Cancer (TNBC)
Phase 3
Completed
240 enrolled
Fudan University
307 Hospital of PLA · collabChanghai Hospital · collabSun Yat-sen University · collabThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences · collabTianjin Medical University Cancer Institute and Hospital · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multi-center, open-labeled, randomized phase III clinical trial comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS) and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine paclitaxel combination (GT).
Timeline
- Start
- 2011-01
- Primary completion
- 2014-03
- Completion
- 2014-03
Outcome
Met primary endpoint
paper the hazard ratio for progression-free survival was 0·692 (95% CI 0·523-0·915; pnon-inferiority<0·0001, psuperiority=0·009, PMID 25795409 ↗
paper thus cisplatin plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine. PMID 25795409 ↗
Publications
- Zhang J, Lin Y, Sun XJ, Wang BY, Wang ZH, Luo JF, Wang LP, Zhang S, Cao J, Tao ZH, Wu J, Shao ZM, Yang WT, Hu XC. Biomarker assessment of the CBCSG006 trial: a randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer. Ann Oncol. 2018 Aug 1;29(8):1741-1747. doi: 10.1093/annonc/mdy209.
- Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM. Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):436-46. doi: 10.1016/S1470-2045(15)70064-1. Epub 2015 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |