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

Pierre Fabre Medicament152 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

152

Conditions

Breast Cancer

Interventions

oral vinorelbineDRUG

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

CapecitabineDRUG

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

Gemcitabine 1250 mg/m²DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Disease Control Rate (DCR)

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

Time frame: From Baseline to disease progression or death, up to 6 years

Data from ClinicalTrials.gov

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