Trial Information
An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer
Inclusion Criteria:
- female patients, >=18 years of age;
- invasive, and operable, breast cancer;
- ECOG Performance Status of 0 or 1.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Percent reduction in IGF-1R expression
Outcome Time Frame:
From initial diagnosis to tumor excision
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Scotland: Scottish Executive Health Department
Study ID:
NP22002
NCT ID:
NCT00882674
Start Date:
July 2009
Completion Date:
December 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms