RANDOMIZED CLINICAL TRIAL TO COMPARE THE BENEFIT OF ADDING HERCEPTIN TO CAPECITABINE PLUS VINORELBINE AS SECOND LINE TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED NON OPERABLE OR METASTATIC BREAST CANCER WITH OVEREXPRESSION OF HER-2, WHO HAVE PROGRESSED TO A PREVIOUS LINE OF TREATMENT FOR METASTATIC DISEASE WITH TRASTUZUMAB IN COMBINATION WITH TAXANES

Conditions: PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER AND OVEREXPRESSION OF HER2.

Registration Number: EUCTR2005-000405-56-ES

Lead Sponsor: GRUPO ESPAÑOL DE INVETIGACION EN CANCER DE MAMA (GEICAM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 82

Inclusion Criteria

Patients must sign an informed consent before of specific procedures of clinical trial.
Patients with histologically confirmed breast cancer and overexpression of HER2.
Age > 18 years.
Patients with locally advanced non operable or mestatatic breast cancer previously treated with a regimen of chemotherapy that included trastuzumab and taxanes.
Clinical measurable or not measurable disease defined by the RECIST criteria.
Women of childbearing potential must have a negative pregnancy test (serum or
urine beta HCG) within 14 days prior to initiation of chemotherapy.
Patients should have adequate organ function to tolerate chemotherapy.
ECOG equal or < 2.
Inclusion of male patients is allowed.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with hypersensitivity reactions to any of the medications of the clinical trial.
Patients who are pregnant or lactating are not eligible.
Active infection or a concomitant serious disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of the treatment in terms of clinical benefit rate.;Secondary Objective: To evaluate time to progression<br>To evaluate objective response Rate <br>To evaluate the profile of toxicity<br>Overall survival <br>Quality of life;Primary end point(s): Clinical benefit will be based on the percentage of patients who had experienced a total o partial response or an estabilization of the disease for a period of time of at least 24 weeks.

Secondary Outcome Measures