A phase III trial of vinflunine + capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant

INTERVENTION: Product Name: Javlor Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Vinflunine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50mg/2ml‐ Trade Name: Xeloda Product Name: Xeloda Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Product Name: Javlor Product Code: L00070 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Vinflunine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 250 mg/10 ml‐ Trade Name: Xeloda Product Name: Xeloda Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: Breast cancer metastatic ; MedDRA version: 11.1 Level: LLT Classification code 10055113 Term: PRIMARY OUTCOME: Main Objective: Primary objective: ; ‐ To compare between the 2 treatment arms the progression free survival. Primary end point(s): The primary endpoint of this study is the progression free survival. Secondary Objective: Secondary objectives: ; ‐ To compare between the 2 arms, ; 1) the overall survival, ; 2) the response rate and the disease control rate, ; 3) the time to response and the duration of response, ; 4) the overall safety, ; 5) the impact of both treatments in the health‐related quality of life. INCLUSION CRITERIA: INCLUSION CRITERIA:· ‐ Patients must give written informed consent (personally signed and dated) before completing any study‐related procedure. ‐ Women with histologically or cytologically confirmed carcinoma of the breast. ‐ Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy. ‐ Patients must have received either one, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting (sequential neoadjuvant/adjuvant treatment counting as one regimen.). ‐ Prior treatments must have included both an anthracycline and a taxane. ‐ Patients must have received a minimum cumulative dose of anthracycline (>or= 180 mg/m² of doxorubicin or >or= 300 mg/m² of epirubicin) or be resistant to an anthracycline according to the following criteria: a) Tumour progression while on anthracycline or within 4 months of the last anthracycline dose when given in the metastati