201 Participants Needed

Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer

Recruiting at 13 trial locations
TT
Ayca Gucalp, MD - MSK Breast Medical ...
Overseen ByAyca Gucalp, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot use certain medications that affect the CYP3A4 enzyme. You may need to switch to alternative medications if yours are strong inducers, inhibitors, or substrates of CYP3A4.

What data supports the effectiveness of the drugs used in the Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer trial?

Research shows that capecitabine, a drug used in the trial, is effective and well-tolerated in treating metastatic breast cancer, and it may offer benefits when used early in the disease. Additionally, eribulin has been shown to improve survival in patients with previously treated metastatic breast cancer.12345

Is Enzalutamide generally safe for humans?

Enzalutamide is generally well tolerated in humans, with most side effects being mild or moderate, but it carries a small increased risk of seizures and other side effects like hot flashes, high blood pressure, and fatigue.678910

How is the drug combination of Enzalutamide and Mifepristone unique for breast cancer treatment?

This treatment is unique because it combines Enzalutamide, an androgen receptor blocker, with Mifepristone, which is known for its use in other conditions like abortion and Cushing's syndrome, to target breast cancer. This combination is novel as it explores the potential of androgen receptor inhibition in breast cancer, which is different from traditional chemotherapy approaches.611121314

Research Team

TT

Tiffany Traina, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I can provide a breast cancer tissue sample for testing.
I have PD-L1 positive breast cancer and was treated with pembrolizumab and chemotherapy, unless I couldn't tolerate checkpoint inhibitors.
I am taking bisphosphonate or denosumab.
See 14 more

Exclusion Criteria

Pregnant patients
I have had seizures or conditions that could lead to seizures.
I have had cancer spread to my brain or its coverings.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enzalutamide, enzalutamide with mifepristone, or chemotherapy in a 21-day cycle

21-day cycles, ongoing until disease progression
Visits every 21 days for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Crossover

Participants on chemotherapy may crossover to enzalutamide plus mifepristone upon disease progression

Treatment Details

Interventions

  • Enzalutamide
  • Mifepristone
  • TPC
Trial Overview 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.
Participant Groups
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.

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇪🇺
Approved in European Union as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇨🇦
Approved in Canada as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇯🇵
Approved in Japan as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Corcept Therapeutics

Industry Sponsor

Trials
72
Recruited
7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Astellas Pharma US, Inc.

Industry Sponsor

Trials
90
Recruited
12,900+

Naoki Okamura

Astellas Pharma US, Inc.

Chief Executive Officer since 2023

Not available

Tadaaki Taniguchi

Astellas Pharma US, Inc.

Chief Medical Officer since 2023

MD, PhD

Breast Cancer Research Foundation

Collaborator

Trials
79
Recruited
40,500+

Findings from Research

Capecitabine is a well-tolerated treatment for metastatic breast cancer, showing minimal side effects like myelosuppression and hair loss, which makes it a promising option for combination therapies with other anticancer drugs.
Ongoing phase II/III trials are investigating the use of capecitabine in early breast cancer treatment, and preliminary results indicate that it may provide significant benefits when used as part of adjuvant and neoadjuvant therapy.
Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer.Fumoleau, P., Cameron, D.[2019]
The combination of eribulin and cyclophosphamide showed a clinical benefit rate of 79.5% in 44 patients with advanced breast cancer, indicating it is an effective treatment option for heavily pretreated individuals.
While the treatment was generally well-tolerated, neutropenia was the most common severe side effect, affecting 47.7% of patients, highlighting the need for monitoring blood cell counts during therapy.
A phase Ib/II study of eribulin in combination with cyclophosphamide in patients with advanced breast cancer.Gumusay, O., Huppert, LA., Magbanua, MJM., et al.[2023]
In a study involving 58 patients with recurrent HER2-negative breast cancer, eribulin showed a median progression-free survival (PFS) of 6.6 months compared to 4.2 months for treatment of physician's choice (TPC), suggesting a potential benefit in delaying disease progression.
Although eribulin demonstrated improved median time to treatment failure (TTF) of 6.0 months versus 3.6 months for TPC, these differences were not statistically significant, indicating that further studies are necessary to confirm the efficacy of eribulin in this setting.
Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19).Aogi, K., Watanabe, K., Kitada, M., et al.[2022]

References

Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. [2019]
A phase Ib/II study of eribulin in combination with cyclophosphamide in patients with advanced breast cancer. [2023]
Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19). [2022]
Phase II interventional study (N0337) of capecitabine in combination with vinorelbine and trastuzumab for first- or second-line treatment of HER2-positive metastatic breast cancer: a north central cancer treatment group trial. [2021]
Impact of the number of prior chemotherapy regimens on outcomes for patients with metastatic breast cancer treated with eribulin: A post hoc pooled analysis. [2021]
Enzalutamide: a review of its use in metastatic, castration-resistant prostate cancer. [2021]
Stevens-Johnson Syndrome Caused by Enzalutamide: A Case Report and Literature Review. [2022]
Enzalutamide-induced severe thrombocytopenia complicated by a seizure in a 76-year-old man with castration-resistant prostate cancer. [2022]
Enzalutamide: a novel antiandrogen for patients with castrate-resistant prostate cancer. [2021]
Pharmacokinetic Drug Interaction Studies with Enzalutamide. [2021]
Enzalutamide: a review of its use in chemotherapy-naïve metastatic castration-resistant prostate cancer. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical activity of enzalutamide versus docetaxel in men with castration-resistant prostate cancer progressing after abiraterone. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Enzalutamide after docetaxel and abiraterone therapy in metastatic castration-resistant prostate cancer. [2021]
Deep and ongoing response of castrate-resistant prostate cancer on very low-dose enzalutamide in an elderly chemotherapy-naïve patient: a case report. [2021]
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