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

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
ATTN-Research Pharmacist
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01597193
Pfizer
Completed
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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