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Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER

NCT01597193•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (17)

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

Key Dates

Start Date

April 30, 2012

Primary Completion Date

December 15, 2015

Completion Date

January 22, 2018

Last Updated

May 8, 2019

Enrollment

101

ACTUAL participants

Conditions

Breast Cancer

Interventions

enzalutamide

DRUG

anastrozole

DRUG

exemestane

DRUG

fulvestrant

DRUG

enzalutamide

DRUG

exemestane

DRUG

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

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RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer