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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01597193

Run by

Pfizer

People needed

101

Starts

2012-04-30

Expected to finish

2018-01-22

Last updated by the study team

2019-05-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• ATTN-Research Pharmacist — Aurora, Colorado, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• University of Colorado Hospital, Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• Connecticut Multispecialty Group — Enfield, Connecticut, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• The West Clinic, PC — Corinth, Mississippi, United States
• The West Clinic — Southaven, Mississippi, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center - IDS Pharmacy — New York, New York, United States
• Memorial Sloan Kettering Cancer Center - OPD Pharmacy — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The West Clinic — Germantown, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• Tennessee Oncology, PLLC. — Nashville, Tennessee, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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