A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
postmenopausal female patients;
stage IV or locally advanced breast cancer;
letrozole failure (Part 2);
Eastern Cooperative Oncology Group (ECOG) performance status <=2.
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.