Clinical trial · Interventional
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
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
NCT03887130CI-TRIAL-00076605completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine 1000 mg/m² | Drug | Gemcitabine | ALIAS |
| Gemcitabine 1250 mg/m² | Drug | Gemcitabine | ALIAS |
| oral vinorelbine | Drug | Vinorelbine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vinorelbine-Capecitabine (arm A)
- description
- oral vinorelbine (OV) with capecitabine (CAP)
- interventionNames
- Drug: oral vinorelbine
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine-Paclitaxel (arm B)
- description
- gemcitabine (GEM) in combination with paclitaxel (PAC)
- interventionNames
- Drug: Gemcitabine 1250 mg/m²
- Drug: Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine-Docetaxel (arm C)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.