drugset / Trial / NCT02520063
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
Phase 1/2
Completed
15 enrolled
University of Alabama at Birmingham
Novartis Pharmaceuticals · collabTracon Pharmaceuticals Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
Timeline
- Start
- 2015-02-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carotuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Carotuximab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |