Phase 2
Completed N=152
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT03887130 ↗Enrolled (actual)
152
Serious AEs
27.5%
Results posted
Apr 2024
Primary outcomePrimary: Disease Control Rate (DCR) — 73.5; 78.0; 80.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate (DCR) |
73.5; 78.0; 80.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03887130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.