Back to resultsStudy of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
oral vinorelbine
Capecitabine
Gemcitabine 1250 mg/m²
Gemcitabine 1000 mg/m²
Paclitaxel
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Vinorelbine-Capecitabine (arm A)
Gemcitabine-Paclitaxel (arm B)
Gemcitabine-Docetaxel (arm C)
Arm Description
oral vinorelbine (OV) with capecitabine (CAP)
gemcitabine (GEM) in combination with paclitaxel (PAC)
gemcitabine (GEM) in combination with docetaxel (DOC)
Outcomes
Primary Outcome Measures
Disease Control Rate (DCR)
Secondary Outcome Measures
Full Information
NCT ID
NCT03887130
First Posted
October 3, 2016
Last Updated
March 20, 2019
Sponsor
Pierre Fabre Medicament
1. Study Identification
Unique Protocol Identification Number
NCT03887130
Brief Title
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vinorelbine-Capecitabine (arm A)
Arm Type
Experimental
Arm Description
oral vinorelbine (OV) with capecitabine (CAP)
Arm Title
Gemcitabine-Paclitaxel (arm B)
Arm Type
Active Comparator
Arm Description
gemcitabine (GEM) in combination with paclitaxel (PAC)
Arm Title
Gemcitabine-Docetaxel (arm C)
Arm Type
Active Comparator
Arm Description
gemcitabine (GEM) in combination with docetaxel (DOC)
Intervention Type
Drug
Intervention Name(s)
oral vinorelbine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
Intervention Type
Drug
Intervention Name(s)
Gemcitabine 1250 mg/m²
Intervention Description
Gemcitabine 1250 mg/m² on day 1 & day 8
Intervention Type
Drug
Intervention Name(s)
Gemcitabine 1000 mg/m²
Intervention Description
Gemcitabine: 1000 mg/m² on day 1 & 8
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 mg/m² on day 1
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75 mg/m² on day 1
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Time Frame
Duration of the study, approximately 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
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