drugset / Trial / NCT00728949
A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether IMC-A12 offers increased progression-free survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast cancer that have experienced disease progression on antiestrogen therapy.
Timeline
- Start
- 2008-08
- Primary completion
- 2012-03
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cixutumumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Anastrozole | Other / unclassified | 1 mg | Oral |
| Comparator | Exemestane | Small molecule | 25 mg | Oral |
| Comparator | Fulvestrant | Small molecule | 250 mg | Intramuscular |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Comparator | Tamoxifen | Small molecule | 20 mg | Oral |