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Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00796107 |
This study will determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer will receive letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks. A second cohort of patients who have either progressed or plateaued on letrozole treatment will receive 3-weekly cycles of combination treatment with letrozole and R1507. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: R1507 Drug: letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 43 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | May 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: R1507
16mg/kg iv every 3 weeks
Drug: letrozole
2.5mg po daily
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: NO21161 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
United States, Florida | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
ATLANTA, Georgia, United States, 30322 | |
United States, Missouri | |
ST. LOUIS, Missouri, United States, 63110 | |
United States, Texas | |
Houston, Texas, United States, 77030 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NO21161 |
Study First Received: | November 21, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00796107 |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Breast Neoplasms Letrozole Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |