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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-27

Study Completion Date

2013-04-18

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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vinorelbine-Capecitabine (arm A)

oral vinorelbine (OV) with capecitabine (CAP)

Group Type EXPERIMENTAL

oral vinorelbine

Intervention Type DRUG

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

Intervention Type DRUG

Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14

Gemcitabine-Paclitaxel (arm B)

gemcitabine (GEM) in combination with paclitaxel (PAC)

Group Type ACTIVE_COMPARATOR

Gemcitabine 1250 mg/m²

Intervention Type DRUG

Gemcitabine 1250 mg/m² on day 1 \& day 8

Paclitaxel

Intervention Type DRUG

Paclitaxel 175 mg/m² on day 1

Gemcitabine-Docetaxel (arm C)

gemcitabine (GEM) in combination with docetaxel (DOC)

Group Type ACTIVE_COMPARATOR

Gemcitabine 1000 mg/m²

Intervention Type DRUG

Gemcitabine: 1000 mg/m² on day 1 \& 8

Docetaxel

Intervention Type DRUG

Docetaxel 75 mg/m² on day 1

Interventions

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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

Intervention Type DRUG

Capecitabine

Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14

Intervention Type DRUG

Gemcitabine 1250 mg/m²

Gemcitabine 1250 mg/m² on day 1 \& day 8

Intervention Type DRUG

Gemcitabine 1000 mg/m²

Gemcitabine: 1000 mg/m² on day 1 \& 8

Intervention Type DRUG

Paclitaxel

Paclitaxel 175 mg/m² on day 1

Intervention Type DRUG

Docetaxel

Docetaxel 75 mg/m² on day 1

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No