Trial information
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
Status: Recruiting
Protocol number: NO21161
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
Brief summary: 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.
Target sample size is
43
.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: R1507
Primary outcome: 1
.
Adverse events (Part 1)
Time frame:
Throughout study
2
.
Objective tumor response (Part 2)
Time frame:
Weeks 6, 12, 18, 24 and then every 12 weeks
Key secondary outcomes: 1. Adverse events and laboratory parameters, PK profile (Part 2) Time frame: Throughout study
2. Progression-free survival, time to progression, time to response (Part 2) Time frame: Event driven
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.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2009
Trial registration date: 11/21/2008
Date last updated: 8/4/2009
Link to trial result
This trial is being conducted at the following locations:
United States
- Birmingham, AL
- Los Angeles, CA
- Washington, DC
- Miami, FL
- Atlanta, GA
- St. Louis, MO
- Houston, TX
- Seattle, WA
