Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

101

Study ID:

NCT01597193

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 12 Locations for this study

See Locations Near You

ATTN-Research Pharmacist
Aurora Colorado, 80045, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
University of Colorado Hospital, Anschutz Outpatient Pavilion
Aurora Colorado, 80045, United States
Connecticut Multispecialty Group
Enfield Connecticut, 06082, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
The West Clinic, PC
Corinth Mississippi, 38834, United States
The West Clinic
Southaven Mississippi, 38671, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10022, United States
Memorial Sloan Kettering Cancer Center - IDS Pharmacy
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center - OPD Pharmacy
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The West Clinic
Germantown Tennessee, 38138, United States
The West Clinic
Memphis Tennessee, 38104, United States
The West Clinic
Memphis Tennessee, 38120, United States
Tennessee Oncology, PLLC.
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

101

Study ID:

NCT01597193

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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