Trial Information
AN OPEN LABEL STUDY TO ASSESS THE EFFECT OF FIRST LINE TREATMENT WITH AVASTIN IN COMBINATION WITH PACLITAXEL AND GEMCITABINE IN PROGRESSION-FREE SURVIVAL IN PATIENTS WITH HER-2 NEGATIVE BREAST CANCER
Inclusion Criteria:
- female patients, >=18 years of age;
- breast cancer, with measurable, locally recurrent or metastatic lesions, or patients
with bone metastasis only;
- HER2-negative disease;
- candidates for chemotherapy;
- ECOG PS of <=2;
Exclusion Criteria:
- previous chemotherapy for metastatic or locally advanced breast cancer;
- previous radiotherapy for treatment of metastatic breast cancer;
- any prior adjuvant treatment with anthracyclines completed <6 months prior to
enrolment;
- chronic daily treatment with corticosteroids (>=10mg/day) aspirin (>325mg/day) or
clopidogrel (>75mg/day);
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Event driven; tumor assessments every 3 cycles
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain:Agencia Espanola del Medicamento
Study ID:
ML21999
NCT ID:
NCT00846027
Start Date:
February 2009
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms