Enzalutamide for Early Stage Breast Cancer

Recruiting at 11 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastatic cancer, Severe disease, Seizure, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 52 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).

Research Team

Tiffany Traina, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for women aged 18 or older with early stage, AR(+) triple negative breast cancer. Participants must have completed any previous treatments at least 4 weeks prior and resolved most side effects. They should be able to take oral medication, not breastfeeding, agree to use dual contraception methods during the study and for three months after. Exclusions include severe diseases, certain blood count levels, absorption disorders, allergies to capsule ingredients, metastatic cancer history or conditions that may cause seizures.

Inclusion Criteria

Women of childbearing potential must have a negative pregnancy test and must agree to use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.

Is not breastfeeding at screening and will not breastfeed throughout the study period and for at least 3 months after final drug administration.

I am fully active or can carry out light work.

Exclusion Criteria

Any severe concurrent disease, infection or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or interferes with the patient's ability to participate in the study requirements.

My breast cancer has spread to other parts of my body.

I haven't had another invasive cancer except for non-dangerous skin cancers or very early stage cancers in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 160mg of enzalutamide orally as daily continuous dosing for 52 weeks

52 weeks

Visits every 4 weeks for the first 12 weeks, then every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enzalutamide

Trial Overview The trial is testing the effectiveness of Enzalutamide as an additional treatment (adjuvant therapy) over a year for patients with early stage AR(+) triple negative breast cancer. The goal is to see if this anti-androgen drug can help prevent cancer recurrence in these patients who have already undergone initial treatment like surgery or chemotherapy.

Participant Groups

Group I: Enzalutamide Experimental Treatment 2 Interventions

160mg orally as daily continuous dosing for 52 weeks. Patients will be seen for protocol visits every 4 weeks (+/- 2 week window) for the first 12 weeks followed by every 12 weeks (+/- 2 week window) to complete 52 weeks. An assessment will also be performed at 52 weeks (+ 4 week window).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Astellas Pharma Inc

Industry Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

Top Products

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Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Medivation, Inc.

Industry Sponsor

Trials

76

Recruited

11,200+

Dr. David Hung

Medivation, Inc.

Chief Executive Officer since 2003

MD from University of California, San Francisco; AB in Biology from Harvard College

Dr. Stephen M. Kelsey

Medivation, Inc.

Chief Medical Officer since 2013

MD from University of Birmingham