drugset / Trial / NCT02207335
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.
Timeline
- Start
- 2013-12
- Primary completion
- 2016-11
- Completion
- 2016-12
Outcome
Missed primary endpoint
paper The trial did not meet the prespecified criteria for the primary endpoint of PFS in patients with advanced TNBC. PMID 39634173 ↗
paper The hazard ratio for PFS was 1.148, and a 95% CI was 0.856-1.539, exceeding the non-inferiority margin of 1.2. PMID 39634173 ↗
Publications
- Liu X, Zhao W, Jia Y, Shi Y, Wang X, Li S, Zhang P, Wang C, Hao C, Tong Z. A non-inferiority, phase III trial of gemcitabine plus capecitabine versus gemcitabine plus carboplatin as first-line therapy and tumor-infiltrating lymphocytes as a prognostic biomarker in patients with advanced triple-negative breast cancer. Ther Adv Med Oncol. 2024 Dec 3;16:17588359241240304. doi: 10.1177/17588359241240304. eCollection 2024.
- Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Background | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |