Clinical trial · Interventional
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer
NCT02207335CI-TRIAL-00020270unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine，Capecitabine | Drug | — | UNRESOLVED |
| Gemcitabine, Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine，Capecitabine
- description
- Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
- interventionNames
- Drug: Gemcitabine，Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine, Carboplatin
- description
- Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
- interventionNames
- Drug: Gemcitabine, Carboplatin
Primary outcomes (1)
- measure
- RECIST 1.1
- timeFrame
- -7 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18-70 years old * ECOG 0-1 * Expected lifetime more than 12 weeks Exclusion Criteria: * Pregnancy * Brain Metastasis, * Severe Infection
References
Publications (2)
- DERIVEDLiu 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. PMID 39634173
- DERIVEDEgger 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. PMID 33084020