Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02750358

Collaborator

Medivation, Inc. (Industry), Astellas Pharma Inc (Industry)

Enrollment

Locations

Arm

83.4

Duration (Months)

4.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Early Stage Triple Negative Breast Cancer	Drug: Enzalutamide Behavioral: assessment	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR(+) Triple Negative Breast Cancer

Study Start Date :

May 19, 2016

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Enzalutamide 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).	Drug: Enzalutamide Behavioral: assessment Other Names: Functional Assessment of Cancer Therapy-Breast (FACT-B) scale

Arm

Intervention/Treatment

Experimental: Enzalutamide

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).

Drug: Enzalutamide

Behavioral: assessment

Other Names:

Functional Assessment of Cancer Therapy-Breast (FACT-B) scale

Outcome Measures

Primary Outcome Measures

The treatment discontinuation rate of enzalutamide in the adherent population [3 years]
feasibility

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

The study population for Step 1 must meet the following eligibility criteria:

Inclusion Criteria:

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+.
AR testing may be performed while patient is undergoing other adjuvant therapy (i.e., surgery, chemotherapy, radiation).
Willing and able to provide informed consent. Woman at least 18 years of age.
Patient is a candidate for treatment of their early stage breast cancer.

The study population for Step 2 will meet the eligibility criteria:

Inclusion Criteria:

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+.
AR(+), defined as ≥1% nuclear staining by IHC testing. The assessment of AR expression may have been performed any time in the past and is not limited to participation in Step 1.
Any neoadjuvant or adjuvant chemotherapy regimen is permitted. Prior chemotherapy for the treatment of this breast cancer is not required.
At least 4 weeks from end of surgery, chemotherapy, or radiotherapy with resolution of any toxicity to Grade 1 or less, excluding alopecia.
Patients are eligible to participate within 6 months of completion of therapy for their breast cancer. This includes prior radiation therapy if needed.
ECOG performance status of 0 or 1.
Willing and able to provide informed consent.
Woman at least 18 years of age.
Able to swallow study drug and comply with study requirements.
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.

Exclusion Criteria:

Each patient eligible to participate in this study must NOT meet any of the following 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.
Evidence of metastatic/Stage 4 breast cancer
History of another invasive cancer within 5 years with the exceptions of nonmelanoma skin cancers and AJCC Stage 0 or 1 cancers that have a remote probability of recurrence in the opinion of the investigator
Absolute neutrophil count < 1500/μL, platelet count < 75,000/μL, or hemoglobin < 9 g/dL (5.6 mmol/L).
Total bilirubin > 1.5 times upper limit of normal (ULN) unless an alternate nonmalignant etiology exists (eg, Gilbert's disease). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times ULN.
Creatinine > 1.5 times ULN or an estimated creatinine clearance < 50 mL/minute calculated using the Cockcroft-Gault equation.
History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months before day 1
An active gastrointestinal disorder affecting absorption (eg, gastrectomy, active peptic ulcer disease, uncontrolled celiac)
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole and butylated hydroxytoluene.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut	United States	06102
2	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
3	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
4	Kings County Hopsital Center	Brooklyn	New York	United States	11203
5	Coney Island Hospital	Brooklyn	New York	United States	11235
6	Woodhull Hospital	Brooklyn	New York	United States
7	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
8	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
9	Queens Hospital Center	Jamaica	New York	United States	11432
10	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
11	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553
12	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18103