drugset / Trial / NCT02457910
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Phase 1/2
Terminated
30 enrolled
Vanderbilt-Ingram Cancer Center
Conquer Cancer Foundation · collabGenentech, Inc. · collabNational Cancer Institute (NCI) · collabTranslational Breast Cancer Research Consortium · collab
RandomizedSequentialOpen-labelTreatment
Summary
This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive triple-negative breast cancer that has spread to other places in the body. Taselisib is a PI3K inhibitor. The PI3K pathway is involved is cancer growth. Androgen may cause the growth of tumor cells. Enzalutamide may stop the growth of tumor cells by blocking the androgen receptor from working. Giving taselisib with enzalutamide may be a better treatment for patients with breast cancer.
Timeline
- Start
- 2015-06
- Primary completion
- 2018-12
- Completion
- 2022-08-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | — | Oral |
| Subject | Taselisib | Small molecule | 2 mg | Oral |
| Subject | Taselisib | Small molecule | 4 mg | Oral |
| Subject | Taselisib | Small molecule | 6 mg | Oral |
| Subject | Taselisib | Small molecule | 8 mg | Oral |