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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: exemestane; Drug: anastrozole; Drug: enzalutamide; Drug: fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01597193

MDV3100-08

C3431006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

101 participants in 5 patient groups

enzalutamide (80-mg with increase to 160 mg)

Experimental group

Description:

enzalutamide be provided as two or four 40-mg capsules by mouth daily

Treatment:

Drug: enzalutamide

Drug: enzalutamide

enzalutamide and anastrozole

Experimental group

Description:

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.

Treatment:

Drug: enzalutamide

Drug: enzalutamide

Drug: anastrozole

enzalutamide and exemestane 25 mg

Experimental group

Description:

enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily

Treatment:

Drug: enzalutamide

Drug: enzalutamide

Drug: exemestane

Drug: exemestane

enzalutamide and exemestane 50 mg

Experimental group

Description:

enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily

Treatment:

Drug: enzalutamide

Drug: enzalutamide

Drug: exemestane

Drug: exemestane

enzalutamide and fulvestrant

Experimental group

Description:

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

Treatment:

Drug: fulvestrant

Drug: enzalutamide

Drug: enzalutamide