Metronomic Oral Chemotherapy With Cyclophosphamide, Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Only males
Description
This is an institutional, monocentric, open-label, phase II study of oral "metronomic" Vinorelbine plus Capecitabine and Cyclophosphamide (VEX) in patients with advanced breast cancer . Patients will receive the combination regimen as follow: Cyclophosphamide 50 mg daily Capecitabine 500 mg, thrice ...
This is an institutional, monocentric, open-label, phase II study of oral "metronomic" Vinorelbine plus Capecitabine and Cyclophosphamide (VEX) in patients with advanced breast cancer . Patients will receive the combination regimen as follow: Cyclophosphamide 50 mg daily Capecitabine 500 mg, thrice daily Vinorelbine 40 mg orally thrice a week Four independent cohorts of patients will be evaluated in the study: Untreated (naïve) patients with endocrine responsive disease Pretreated patients with endocrine responsive disease Untreated (naïve) patients with triple negative disease Pretreated patients with triple negative disease Combination will be administered until disease progression or unacceptable toxicity. The primary endpoint will be to assess the Time to progression (TTP) of VEX combination in the four different cohorts
Tracking Information
- NCT #
- NCT04304352
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marco Colleoni, MD European Institute of Oncology
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