Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

• Status: Completed
• Trial end date: 2018-01-22
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.; Pfizer
• Collaborators: Astellas Pharma Inc; Medivation is now a wholly owned subsidiary of Pfizer Inc.; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Treatments: Anastrozole; Estradiol; Exemestane; Fulvestrant

Criteria

Inclusion Criteria:

• Histologically confirmed breast cancer with accompanying pathology report;

• Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides

• Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);

• Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;

• Estimated life expectancy of at least 3 months

Exclusion Criteria:

• Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;

• Pregnant or lactating;

• Known or suspected brain metastasis or leptomeningeal disease;

• History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;

• For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.