- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887130
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
March 20, 2019 updated by: Pierre Fabre Medicament
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vinorelbine-Capecitabine (arm A)
oral vinorelbine (OV) with capecitabine (CAP)
|
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
Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
|
ACTIVE_COMPARATOR: Gemcitabine-Paclitaxel (arm B)
gemcitabine (GEM) in combination with paclitaxel (PAC)
|
Gemcitabine 1250 mg/m² on day 1 & day 8
Paclitaxel 175 mg/m² on day 1
|
ACTIVE_COMPARATOR: Gemcitabine-Docetaxel (arm C)
gemcitabine (GEM) in combination with docetaxel (DOC)
|
Gemcitabine: 1000 mg/m² on day 1 & 8
Docetaxel 75 mg/m² on day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease Control Rate (DCR)
Time Frame: Duration of the study, approximately 6 months
|
Duration of the study, approximately 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
March 20, 2019
First Posted (ACTUAL)
March 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 22, 2019
Last Update Submitted That Met QC Criteria
March 20, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Docetaxel
- Paclitaxel
- Capecitabine
- Vinorelbine
Other Study ID Numbers
- PM0259CA223B0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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