Status:
COMPLETED
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor ...
Eligibility Criteria
Inclusion
- female participants, age \>/=18 years
- advanced, inflammatory or early stage unilateral invasive breast cancer
- HER2-positive breast cancer
- baseline left ventricular ejection fraction (LVEF) \>/=55%
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00976989
Start Date
November 1 2009
End Date
January 1 2016
Last Update
February 6 2017
Active Locations (55)
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1
Banja Luka, Bosnia and Herzegovina, 78000
2
Sarajevo, Bosnia and Herzegovina, 71000
3
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
4
São Paulo, São Paulo, Brazil, 01317-000