Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
NCT ID: NCT01597193
Last Updated: 2019-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
101 participants
INTERVENTIONAL
2012-04-30
2018-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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enzalutamide (80-mg with increase to 160 mg)
enzalutamide be provided as two or four 40-mg capsules by mouth daily
enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
enzalutamide and anastrozole
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.
anastrozole
1 mg/day
enzalutamide
160 mg (4 capsules) taken orally daily.
enzalutamide and exemestane 25 mg
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily
exemestane
The exemestane dose is 25mg daily.
enzalutamide
160 mg (4 capsules) taken orally daily.
enzalutamide and exemestane 50 mg
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily
enzalutamide
160 mg (4 capsules) taken orally daily.
exemestane
The exemestane dose is 50 mg daily.
enzalutamide and fulvestrant
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days
fulvestrant
500 mg every 28 days
enzalutamide
160 mg (4 capsules) taken orally daily.
Interventions
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enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
anastrozole
1 mg/day
exemestane
The exemestane dose is 25mg daily.
fulvestrant
500 mg every 28 days
enzalutamide
160 mg (4 capsules) taken orally daily.
exemestane
The exemestane dose is 50 mg daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Other Identifiers
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C3431006
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-08
Identifier Type: -
Identifier Source: org_study_id
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