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Hormone Therapy

Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer

Q: Has Enzalutamide been granted regulatory clearance by the FDA?

<p>Our evaluation of <a href="https://www.withpower.com/clinical-trials/enzalutamide">Enzalutamide</a>'s safety was a 2, as Phase 2 trials have not yet yielded evidence for its efficacy but do provide some insight into the drug's security.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I can provide a breast cancer tissue sample for testing.

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

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I am 18 years old or older.

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I can swallow pills without any issues.

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

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My tumor is androgen receptor positive.

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I can take care of myself and perform daily activities.

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I do not have any other cancer that needs treatment.

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My breast cancer cannot be surgically removed and has spread.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

progression-free survival (PFS)

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

~2760

Mifepristone

2013

Completed Phase 4

~3080

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsIndustry Sponsor

68 Previous Clinical Trials

6,179 Total Patients Enrolled

1 Trials studying Breast Cancer

37 Patients Enrolled for Breast Cancer

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,697 Total Patients Enrolled

203 Trials studying Breast Cancer

81,103 Patients Enrolled for Breast Cancer

Astellas Pharma US, Inc.Industry Sponsor

88 Previous Clinical Trials

12,632 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple facilities in the US offering this clinical research?

"Presently, 6 clinical trial sites are enrolling participants in this research endeavor. The cities of San Francisco, Chicago and Boston host these clinics along with another trio of locations. To impose the least amount of travel demands on potential enrollees, it is wise to pick the clinic nearest you."

Answered by AI

Are new participants being taken on for this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that as of October 19th, 2023 this medical study is actively recruiting for 201 participants across 6 sites. This trial was first posted on the 18th of October in the same year."

Answered by AI

Has Enzalutamide been granted regulatory clearance by the FDA?

"Our evaluation of Enzalutamide's safety was a 2, as Phase 2 trials have not yet yielded evidence for its efficacy but do provide some insight into the drug's security."

Answered by AI

How many participants have signed up for this medical trial?

"Affirmative. According to information on clinicaltrials.gov, the trial is actively searching for potential participants as of October 19th 2023. The study was first posted one day prior and is currently enrolling 201 patients across 6 medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

2023. "A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099769.