An Exploratory Single-arm Study to Evaluate the Effect of Pertuzumab in Combination With Herceptin on Response Rate in Patients With HER2-positive Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
An Exploratory Single-arm Study to Evaluate the Effect of Pertuzumab in Combination With Herceptin on Response Rate in Patients With HER2-positive Metastatic Breast Cancer
Inclusion Criteria:
- Adult patients, >=18 years of age, with histologically-confirmed HER2-positive breast
cancer
- Metastatic breast cancer, with progression on Herceptin-based therapy as last
treatment for metastatic disease
- <=3 chemotherapy regimens prior to study entry
- Last Herceptin dose <=9 weeks before study entry for patients reciving pertuzumab +
Herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy
- LVEF>= 55% at study entry
Exclusion Criteria:
- Previous treatment with an anti-cancer vaccine or any targeted therapy other than
Herceptin
- Brain metastases
- History of any cardiac AE related to Herceptin therapy
- Any other malignancy in the last 5 years, except for basal cell cancer or cancer in
situ of the cervix
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
BO17929
NCT ID:
NCT01674062
Start Date:
May 2006
Completion Date:
December 2016
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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