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Clinical Trial Details

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Brief Title Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Official Title A Phase Ib/II Trial of Taselisib (GDC-0032), a PI3K Inhibitor, in Combination With Enzalutamide in Patients With Androgen Receptor Positive Triple Negative Metastatic Breast Cancer
Principal Investigator Nanda, Rita
Brief 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.
Gender Both
Ages 18 Years
Enrollment 74
Accepts Healthy Volunteers No
Lead Sponsor Vanderbilt-Ingram Cancer CenterOther
Collaborator National Cancer Institute (NCI)NIH
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1/Phase 2
Study Type Interventional
Contact Name Paula Pholmann, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Estrogen Receptor Negative
Detail for Health Professional (on clinicaltrials.gov)
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