Trial Information
Inclusion Criteria:
- female patients, age >/=18 years
- advanced, inflammatory or early stage unilateral invasive breast cancer
- HER2-positive breast cancer
- baseline LVEF >/=55%
Exclusion Criteria:
- metastatic disease (Stage IV) or bilateral breast cancer
- previous anticancer therapy or radiotherapy for any malignancy
- other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
- clinically relevant cardiovascular disease
- current chronic treatment with corticosteroids of >10mg methylprednisolone or
equivalent
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:
Tolerability during neoadjuvant treatment: symptomatic cardiac events, LVEF
Outcome Time Frame:
throughout cycles 1-6, complete cardiac questionnaire every 3 weeks, LVEF cycles 2, 4 and 6
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
BO22280
NCT ID:
NCT00976989
Start Date:
December 2009
Completion Date:
August 2016
Related Keywords:
- Breast Cancer
- Breast Neoplasms