Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
Phase 3
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: Gemcitabine，Capecitabine
- Registration Number
- NCT02207335
- Brief 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.
- Detailed Description
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.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
- Female
- 18-70 years old
- ECOG 0-1
- Expected lifetime more than 12 weeks
Exclusion Criteria
- Pregnancy
- Brain Metastasis,
- Severe Infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine，Capecitabine Gemcitabine，Capecitabine Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14 Gemcitabine, Carboplatin Gemcitabine, Carboplatin Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
- Primary Outcome Measures
Name Time Method RECIST 1.1 -7 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China