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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Enzalutamide; Drug: exemestane; Drug: Placebo (for enzalutamide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02007512

MDV3100-12

2013-002717-35 (EudraCT Number)

C3431008 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Enrollment: 247 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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247 participants in 2 patient groups

Enzalutamide & exemestane

Experimental group

Description:

Enzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food.

Treatment:

Drug: exemestane

Drug: exemestane

Drug: Enzalutamide

Placebo & exemestane

Active Comparator group

Description:

Placebo and exemestane 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet without placebo after unblinding) once daily after food.

Treatment:

Drug: Placebo (for enzalutamide)

Drug: exemestane

Drug: exemestane