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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Gemcitabine 1250 mg/m²; Drug: oral vinorelbine; Drug: Gemcitabine 1000 mg/m²; Drug: Capecitabine; Drug: Paclitaxel; Drug: Docetaxel

• Registration Number: NCT03887130
• Lead Sponsor: Pierre Fabre Medicament

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-27
• Primary Completion: 2013-04-18
• Study Completion: 2013-04-18
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Status Verified: 2024-02
• Results First Submitted: 2024-02-08
• Results First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Results First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vinorelbine-Capecitabine (arm A)	Capecitabine	oral vinorelbine (OV) with capecitabine (CAP)
Gemcitabine-Paclitaxel (arm B)	Gemcitabine 1250 mg/m²	gemcitabine (GEM) in combination with paclitaxel (PAC)
Gemcitabine-Paclitaxel (arm B)	Paclitaxel	gemcitabine (GEM) in combination with paclitaxel (PAC)
Gemcitabine-Docetaxel (arm C)	Docetaxel	gemcitabine (GEM) in combination with docetaxel (DOC)
Vinorelbine-Capecitabine (arm A)	oral vinorelbine	oral vinorelbine (OV) with capecitabine (CAP)
Gemcitabine-Docetaxel (arm C)	Gemcitabine 1000 mg/m²	gemcitabine (GEM) in combination with docetaxel (DOC)

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	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