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Metronomic Oral Chemotherapy With Cyclophosphamide, Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients — VEX  

Advanced Breast Cancer Clinical Trial

Official title:
A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients

Clinical Trial Summary

This is a phase II study assessing the activity and safety of metronomic chemotherapy with cyclophosphamide and capecitabine and vinorelbine in advanced breast cancer patient in four different cohort of patients: 1. Untreated (naïve) patients with endocrine responsive disease 2. Pretreated patients with endocrine responsive disease 3. Untreated (naïve) patients with triple negative disease 4. Pretreated patients with triple negative disease The primary endpoint will be the progression-free survival

Clinical Trial 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 daily Vinorelbine 40 mg orally thrice a week Four independent cohorts of patients will be evaluated in the study: 1. Untreated (naïve) patients with endocrine responsive disease 2. Pretreated patients with endocrine responsive disease 3. Untreated (naïve) patients with triple negative disease 4. 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04304352
Study type Interventional
Source European Institute of Oncology
Contact Emilia Montagna, MD
Phone +390257489243
Email emilia.montagna@ieo.it
Status Recruiting
Phase Phase 2
Start date July 29, 2011
Completion date December 31, 2023
View Details
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