Trial Information
A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer
Inclusion Criteria:
- female patients, >=18 years of age;
- locally advanced, inflammatory or early stage invasive breast cancer;
- HER2 positive (HER2+++ by IHC or FISH/CISH+).
Exclusion Criteria:
- metastatic disease (Stage IV) or bilateral breast cancer;
- previous anticancer therapy or radiotherapy for any malignancy;
- other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
- insulin-dependent diabetes;
- clinically relevant cardiovascular disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete response rate
Outcome Time Frame:
Post-surgery
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: AIFA (Agenzia Italiana Farmaco)
Study ID:
WO20697
NCT ID:
NCT00545688
Start Date:
December 2007
Completion Date:
February 2015
Related Keywords:
- Breast Cancer
- Breast Neoplasms