Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Breast Cancer
In brief
The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.
Key facts
- Study ID
- NCT02007512
- Run by
- Pfizer
- People needed
- 247
- Starts
- 2013-12-16
- Expected to finish
- 2024-08-23
- Last updated by the study team
- 2025-09-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Willing and able to provide informed consent;
- Postmenopausal;
- Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;
- Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;
- Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;
- Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;
You may not qualify if…
- Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;
- Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator;
- Current or previously treated brain metastasis or leptomeningeal disease;
- Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible);
- Requires treatment for tuberculosis or HIV infection;
- Radiation therapy within 7 days before randomization;
- History of another invasive cancer within 5 years before randomization;
- History of seizure or any condition that may predispose to seizure;
- Clinically significant cardiovascular disease;
- Active gastrointestinal disorder;
- Major surgery within 28 days prior to randomization;
- Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;
- Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;
- Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;
- Hypersensitivity reaction to exemestane.
Where it is running
- University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
- University of Colorado Hospital, Anschutz Outpatient Pavilion — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
- Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
- Florida Cancer Specialists — Altamonte Springs, Florida, United States
- Florida Cancer Specialists — Bonita Springs, Florida, United States
- Florida Cancer Specialists — Bradenton, Florida, United States
- Florida Cancer Specialists — Brandon, Florida, United States
- Florida Cancer Specialists — Cape Coral, Florida, United States
- Florida Cancer Specialists — Clearwater, Florida, United States
- Florida Cancer Specialists — Englewood, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialists — Gainesville, Florida, United States
- Florida Cancer Specialists — Hudson, Florida, United States
- Florida Cancer Specialists — Largo, Florida, United States
- Florida Cancer Specialists — Naples, Florida, United States
- Florida Cancer Specialists — New Port Richey, Florida, United States
- Florida Cancer Specialists — Orange City, Florida, United States
- Florida Cancer Specialists — Orlando, Florida, United States
- Florida Cancer Specialists — Port Charlotte, Florida, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- ATTN-Research Pharmacist — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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