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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

No Placebo-Only Group

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.

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.

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.

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I have a history of seizures or conditions that could lead to seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

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

Primary study objectives

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%

Constipation

13%

Diarrhoea

12%

Pain in extremity

12%

Weight decreased

11%

Anaemia

11%

Musculoskeletal pain

Hypertension

Oedema peripheral

Haematuria

Dizziness

Malignant neoplasm progression

Insomnia

Hot flush

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pulmonary embolism

Pneumonia

Pyrexia

Renal failure

Neutropenia

Cardiac failure

Lower respiratory tract infection

Osteoarthritis

Urinary tract infection

Metastases to central nervous system

Lung disorder

100%

80%

60%

40%

20%

Study treatment Arm

Enzalutamide Total

Awards & Highlights

No Placebo-Only Group

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

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

~3820

assessment

2010

N/A

~7960