A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/3/2016 |
| Start Date: | January 2009 |
| End Date: | June 2010 |
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.
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.
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.
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.
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