Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: oral vinorelbine
* Drug: Capecitabine
* Drug: Gemcitabine 1250 mg/m²
* Drug: Gemcitabine 1000 mg/m²
* Drug: Paclitaxel
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vinorelbine-Capecitabine (arm A)<br>oral vinorelbine (OV) with capecitabine (CAP) | Drug: oral vinorelbine<br>* Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles<br>Drug: Capecitabine<br>* Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14<br>|
| Active Comparator: Gemcitabine-Paclitaxel (arm B)<br>gemcitabine (GEM) in combination with paclitaxel (PAC) | Drug: Gemcitabine 1250 mg/m²<br>* Gemcitabine 1250 mg/m² on day 1 & day 8<br>Drug: Paclitaxel<br>* Paclitaxel 175 mg/m² on day 1<br>|
| Active Comparator: Gemcitabine-Docetaxel (arm C)<br>gemcitabine (GEM) in combination with docetaxel (DOC) | Drug: Gemcitabine 1000 mg/m²<br>* Gemcitabine: 1000 mg/m² on day 1 & 8<br>Drug: Docetaxel<br>* Docetaxel 75 mg/m² on day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) |  | Duration of the study, approximately 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer