Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- oral vinorelbine
- Conditions
- Breast Cancer
- Sponsor
- Pierre Fabre Medicament
- Enrollment
- 152
- Primary Endpoint
- Disease Control Rate (DCR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the breast;
- •Documented metastatic disease previously untreated by chemotherapy;
- •HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
- •Karnofsky Performance Status 70%.
Exclusion Criteria
- •Local relapse alone after conservative treatment or contra-lateral tumor;
- •Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
- •Concomitant hormonal therapy for metastatic breast cancer;
- •Prior chemotherapy in the metastatic setting;
- •Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
- •Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.
Arms & Interventions
Vinorelbine-Capecitabine (arm A)
oral vinorelbine (OV) with capecitabine (CAP)
Intervention: oral vinorelbine
Vinorelbine-Capecitabine (arm A)
oral vinorelbine (OV) with capecitabine (CAP)
Intervention: Capecitabine
Gemcitabine-Paclitaxel (arm B)
gemcitabine (GEM) in combination with paclitaxel (PAC)
Intervention: Gemcitabine 1250 mg/m²
Gemcitabine-Paclitaxel (arm B)
gemcitabine (GEM) in combination with paclitaxel (PAC)
Intervention: Paclitaxel
Gemcitabine-Docetaxel (arm C)
gemcitabine (GEM) in combination with docetaxel (DOC)
Intervention: Gemcitabine 1000 mg/m²
Gemcitabine-Docetaxel (arm C)
gemcitabine (GEM) in combination with docetaxel (DOC)
Intervention: Docetaxel
Outcomes
Primary Outcomes
Disease Control Rate (DCR)
Time Frame: From Baseline to disease progression or death, up to 6 years
Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable disease: no partial response or progression of the disease