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Enzalutamide for Early Stage Breast Cancer

Phase 2
Waitlist Available
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
ECOG performance status of 0 or 1.
Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER <1%, PR <1% and HER2 0 or 1+ or FISH not amplified if IHC 2+.
Must not have
Evidence of metastatic/Stage 4 breast cancer
Creatinine > 1.5 times ULN or an estimated creatinine clearance < 50 mL/minute calculated using the Cockcroft-Gault equation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial is testing whether a year of treatment with the drug enzalutamide can help treat early stage triple negative breast cancer that is positive for the androgen receptor.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, hot flashes, joint pain or swelling; it can also affect mood causing anxiety or depression. There's a risk of high blood pressure and rare but serious side effects like seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My breast cancer is early stage and lacks ER, PR, and HER2 receptors.
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It's been over 4 weeks since my last cancer treatment and any side effects are mild, except for hair loss.
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My breast cancer is early stage and lacks ER, PR, and HER2 receptors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer has spread to other parts of my body.
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My kidney function is below the normal range.
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I have a stomach or bowel problem that affects how my body absorbs food.
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I am allergic to specific ingredients in the medication's capsule.
Select...
I have a history of seizures or conditions that could lead to seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
The treatment discontinuation rate of enzalutamide in the adherent population

Side effects data

From 2017 Phase 4 trial • 215 Patients • NCT02116582
34%
Fatigue
25%
Decreased appetite
18%
Asthenia
17%
Back pain
16%
Arthralgia
15%
Nausea
13%
Bone pain
13%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total

Trial Design

1Treatment groups
Experimental Treatment
Group I: EnzalutamideExperimental Treatment2 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
assessment
2010
N/A
~7960

Find a Location

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor
694 Previous Clinical Trials
233,206 Total Patients Enrolled
6 Trials studying Breast Cancer
458 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,701 Total Patients Enrolled
203 Trials studying Breast Cancer
81,506 Patients Enrolled for Breast Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,192 Total Patients Enrolled
2 Trials studying Breast Cancer
247 Patients Enrolled for Breast Cancer

Media Library

Enzalutamide Clinical Trial Eligibility Overview. Trial Name: NCT02750358 — Phase 2
Breast Cancer Research Study Groups: Enzalutamide
Breast Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02750358 — Phase 2
Enzalutamide 2023 Treatment Timeline for Medical Study. Trial Name: NCT02750358 — Phase 2
~4 spots leftby May 2025
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