Trial Information
An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
Inclusion Criteria:
- postmenopausal female patients;
- stage IV or locally advanced breast cancer;
- measurable disease;
- letrozole failure (Part 2);
- ECOG performance status <=2.
Exclusion Criteria:
- previous chemotherapy for metastatic breast cancer;
- concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to
receipt of study drug;
- history of primary malignancy in 5 years prior to study, excluding adequately treated
basal or squamous cell cancer of skin, or cancer in situ of cervix;
- concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study
drug.
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:
Adverse events (Part 1)
Outcome Time Frame:
Throughout study
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:
NO21161
NCT ID:
NCT00796107
Start Date:
January 2009
Completion Date:
June 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|
Albany, Georgia 31701 |
|
Birmingham, Alabama 35294 |
|
Miami, Florida 33176 |
|
Columbia, Missouri 65203 |
|
Austin, Texas 78705 |
|
Washington, District of Columbia |