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

April 2, 2024 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

Intervention / Treatment

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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vinorelbine-Capecitabine (arm A)
oral vinorelbine (OV) with capecitabine (CAP)
Drug: oral vinorelbine
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
Drug: Capecitabine
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)
Drug: Gemcitabine 1250 mg/m²
Gemcitabine 1250 mg/m² on day 1 & day 8
Drug: Paclitaxel
Paclitaxel 175 mg/m² on day 1
Active Comparator: Gemcitabine-Docetaxel (arm C)
gemcitabine (GEM) in combination with docetaxel (DOC)
Drug: Gemcitabine 1000 mg/m²
Gemcitabine: 1000 mg/m² on day 1 & 8
Drug: Docetaxel
Docetaxel 75 mg/m² on day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: From Baseline to disease progression or death, up to 6 years

Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:

Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

Stable disease: no partial response or progression of the disease
From Baseline to disease progression or death, up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

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 (Actual)

March 27, 2007

Primary Completion (Actual)

April 18, 2013

Study Completion (Actual)

April 18, 2013

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)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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