← Back to Search

Hormone Therapy

Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer

Phase 2

Recruiting

Led By Tiffany Traina, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A representative, formalin-fixed, paraffin-embedded tumor specimen that enables the diagnosis of breast cancer, with adequate viable tumor cells in a tissue block or 15 freshly cut unstained slides and 1 H&E slide

Patients with PD-L1 positive breast cancer (CPS ≥ 10) should have received prior treatment with pembrolizumab in combination with chemotherapy in the first line setting unless there is a contraindication to checkpoint inhibitor therapy

Must not have

History of seizure or any condition that may predispose to seizure at any time in the past

History of brain metastases or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if two drugs can effectively treat advanced triple negative or ER-low breast cancer, compared to standard chemotherapy.

Who is the study for?

This trial is for adults with advanced breast cancer that's spread and tests positive for certain receptors. They can have had one chemo treatment before, but not specific other treatments or conditions like brain metastases. Participants need to be able to take pills, have no severe diseases that could interfere, and agree to use two forms of birth control.

What is being tested?

The study compares the effectiveness of Enzalutamide alone or combined with Mifepristone against standard chemotherapies (carboplatin, paclitaxel, capecitabine, eribulin) in treating advanced receptor-positive breast cancers. It aims to determine which method works best.

What are the potential side effects?

Possible side effects include fatigue, nausea, skin rash from Enzalutamide; weight changes and abdominal pain from Mifepristone; hair loss and nerve damage from chemotherapy drugs like paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can provide a breast cancer tissue sample for testing.

Select...

I have PD-L1 positive breast cancer and was treated with pembrolizumab and chemotherapy, unless I couldn't tolerate checkpoint inhibitors.

Select...

I am 18 years old or older.

Select...

I can swallow pills without any issues.

Select...

I am eligible for chemotherapy with eribulin, capecitabine, paclitaxel, or carboplatin.

Select...

My tumor is androgen receptor positive.

Select...

I can take care of myself and perform daily activities.

Select...

I do not have any other cancer that needs treatment.

Select...

My breast cancer cannot be surgically removed and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had seizures or conditions that could lead to seizures.

Select...

I have had cancer spread to my brain or its coverings.

Select...

I am not taking drugs that strongly affect liver enzyme CYP3A4.

Select...

I do not have any severe illness that would prevent me from joining.

Select...

I have previously undergone antiandrogen therapy.

Select...

I have had unexplained vaginal bleeding or a diagnosis of endometrial issues.

Select...

I have a stomach or intestine problem that affects how my body absorbs food.

Select...

I am currently taking corticosteroids every day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enzalutamide with MifepristoneExperimental Treatment2 Interventions

Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle

Group II: EnzalutamideExperimental Treatment1 Intervention

Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle

Group III: Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC)Active Control1 Intervention

The treating physician must select from one of the following regimens. * Eribulin 1.4 mg/m2 IV Day 1 and Day 8 in a 21-day cycle * Capecitabine 1000-1250 mg/m2 twice daily, orally Day 1-14 in a 21-day cycle * Paclitaxel 80 mg/m2 IV Day 1, Day 8 in a 21-day cycle * Carboplatin AUC 6 IV Day 1 in a 21-day cycle * Carboplatin AUC 2 IV Day 1, Day 8 and Day 15 in a 21-day cycle Patients randomized to TPC may be offered crossover to enzalutamide plus mifepristone treatment at the time of disease progression if they continue to meet eligibility criteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

Mifepristone

2013

Completed Phase 4

~3080