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

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine 1000 mg/m²; Drug: oral vinorelbine; Drug: Capecitabine; Drug: Docetaxel; Drug: Paclitaxel; Drug: Gemcitabine 1250 mg/m²

Study type: Interventional

Funder types: Industry

Identifiers

NCT03887130

PM0259CA223B0

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 3 patient groups

Vinorelbine-Capecitabine (arm A)

Experimental group

Description:

oral vinorelbine (OV) with capecitabine (CAP)

Treatment:

Drug: Capecitabine

Drug: oral vinorelbine

Gemcitabine-Paclitaxel (arm B)

Active Comparator group

Description:

gemcitabine (GEM) in combination with paclitaxel (PAC)

Treatment:

Drug: Paclitaxel

Drug: Gemcitabine 1250 mg/m²

Gemcitabine-Docetaxel (arm C)

Active Comparator group

Description:

gemcitabine (GEM) in combination with docetaxel (DOC)

Treatment:

Drug: Gemcitabine 1000 mg/m²

Drug: Docetaxel