At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 140 enrolled
Drug / intervention
Paclitaxel +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Metronomic Oral Vinorelbine Plus Cyclophosphamide and Capecitabine (VEX) Versus Weekly Paclitaxel as First-line or Second-line Treatment in Patients With ER-positive/HER2-negative Advanced or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Cyclophosphamide, and 2 other interventions for Breast Cancer. Completed, enrolled 140 participants across 20 sites.
Detailed Summary
This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of vinorelbine plus cyclophosphamide and capecitabine, or the conventional paclitaxel monotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartSep 2017
Primary CompletionNov 2021
Study CompletionNov 2022
TodayJul 2026
First PostedNov 3, 2016
Enrollment StartSep 13, 2017
Primary CompletionNov 17, 2021
Study CompletionNov 23, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.7 years ago
Interventions
Paclitaxeldrug
Arm A
Cyclophosphamidedrug
Arm B
Capecitabinedrug
Arm B
Vinorelbinedrug
Arm B