Enzalutamide for Early Stage Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests enzalutamide, a medication targeting certain hormones, to determine its effectiveness in treating early-stage triple-negative breast cancer, which lacks three common receptors. The goal is to assess whether taking enzalutamide for a year is practical and beneficial for patients with this specific cancer. Participants must have a diagnosis of early-stage, triple-negative breast cancer and a positive test for androgen receptors. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that enzalutamide is likely to be safe for humans?

Research has shown that enzalutamide is generally well-tolerated. It is already approved for treating high-risk prostate cancer, indicating a good safety record for that condition. In studies with enzalutamide, many patients required fewer additional cancer treatments, demonstrating its effectiveness and safety in slowing disease progression.

While some side effects have been reported, they are usually manageable. Common side effects include fatigue and hot flashes, but serious issues are rare. This trial is in an early stage and aims to understand the treatment's safety and any possible side effects in individuals with early-stage AR-positive triple-negative breast cancer.

Overall, previous research suggests that enzalutamide has a favorable safety profile, especially compared to other cancer treatments. However, prospective participants should discuss any concerns with the trial team to understand what this might mean personally. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard treatments for early-stage breast cancer, which often include surgery, chemotherapy, and hormone therapy, Enzalutamide offers a novel approach by targeting androgen receptors. This is significant because while most breast cancer therapies focus on estrogen or HER2 receptors, Enzalutamide works differently, potentially offering a new pathway for treatment. Researchers are excited about Enzalutamide because it could provide an effective option for patients whose tumors are driven by androgen signals, an area not fully addressed by current therapies.

What evidence suggests that enzalutamide might be an effective treatment for early stage breast cancer?

Research has shown that enzalutamide, a medication that blocks certain hormones, holds promise for treating early-stage triple-negative breast cancer with specific receptor positivity. Previous studies found that women with advanced breast cancer generally tolerated enzalutamide well, and it showed positive effects in these patients. In men, it significantly delayed the need for additional cancer treatments, suggesting it might effectively manage cancer progression. Although final conclusions about its effectiveness in early-stage breast cancer are premature, these initial findings are encouraging. Participants in this trial will receive enzalutamide as an experimental treatment to further evaluate its potential benefits in early-stage breast cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Tiffany Traina, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10506398/

Adjuvant enzalutamide for the treatment of early-stage ... This study demonstrates that 1 year of adjuvant enzalutamide is feasible and well-tolerated in patients with early-stage AR+ TNBC, as the ...

2. xtandi.com xtandi.com/clinical-trials

Clinical Trial Results | XTANDI® (enzalutamide) During the study, men taking XTANDI had a 79% reduction in risk of starting their next cancer treatment, including chemo. The delay in the median time was 40 ...

3. aacrjournals.org aacrjournals.org/clincancerres/article/26/23/6149/82876/A-Randomized-Placebo-Controlled-Phase-II-Trial

A Randomized Placebo Controlled Phase II Trial Evaluating ... Enzalutamide is well tolerated in women with advanced breast cancer (17) and has demonstrated clinical activity in women with advanced AR+ triple-negative ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS1138

TBCRC 058: A randomized phase II study of enzalutamide ... This randomized study will evaluate the efficacy of enzalutamide or enzalutamide plus the GR antagonist mifepristone (mif) as compared to physician's choice ...

5. cancerresearchuk.org cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-enzalutamide-for-early-stage-breast-cancer-arb

A trial looking at enzalutamide for early stage breast cancer ... This trial is investigating whether the hormone treatment enzalutamide is a useful treatment for women with breast cancer before they have surgery.

6. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/fda-xtandi-prostate-cancer-psa-recurrence

Xtandi Approved for High-Risk Prostate Cancer - NCI In the trial, patients treated with the combination of enzalutamide and leuprolide had better metastasis-free survival than those treated with ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT127869

Enzalutamide plus exemestane: A pilot study to assess ... Preliminary data indicate that ENZA + EXE 50 mg achieves similar EXE exposure to EXE 25 mg alone (AUC=127±70 vs. 131±64 ng.h/mL) and maintains estrogen ...