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Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

NCT02007512

CompletedPhase 2

Sponsor: Pfizer

Conditions: Breast Cancer

Interventions: Enzalutamide, exemestane, Placebo (for enzalutamide), exemestane

Countries: United States, Belgium, Canada, Ireland, Italy, Spain, United Kingdom

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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.

Locations (135)

Aurora, Colorado, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Lone Tree, Colorado, United States
Altamonte Springs, Florida, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Englewood, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hudson, Florida, United States
Largo, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
Sarasota, Florida, United States
Spring Hill, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
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