A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Phase 1
Completed
- Conditions
- Breast Cancer
- Interventions
- Drug: RG1507
- Registration Number
- NCT00882674
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is \< 3 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8
Inclusion Criteria
- female patients, >=18 years of age;
- invasive, and operable, breast cancer;
- ECOG Performance Status of 0 or 1.
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Exclusion Criteria
- evidence of metastatic disease;
- inflammatory breast cancer;
- prior hormonal or systemic therapy for breast cancer;
- prior treatment with an agent targetting the IGF-1R pathway;
- patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 RG1507 -
- Primary Outcome Measures
Name Time Method Percent reduction in IGF-1R expression From initial diagnosis to tumor excision
- Secondary Outcome Measures
Name Time Method Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue Days 1, 8 and 31 Adverse events, laboratory parameters Throughout study