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

This study is currently recruiting participants.
Verified September 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02750358
First Posted: April 25, 2016
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Medivation, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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 Intervention Phase
Breast Cancer Early Stage Triple Negative Breast Cancer Drug: Enzalutamide Behavioral: assessment Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • The treatment discontinuation rate of enzalutamide in the adherent population [ Time Frame: 3 years ]
    feasibility


Estimated Enrollment: 200
Study Start Date: May 19, 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Functional Assessment of Cancer Therapy-Breast (FACT-B) scale

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750358


Contacts
Contact: Tiffany Traina, MD 646-888-4558
Contact: Ayca Gucalp, MD 646-888-4536

Locations
United States, Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Patricia DeFusco, MD    860-246-6647      
United States, New Jersey
Memorial Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Tiffany Traina, MD    646-888-4558      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Tiffany Traina, MD    646-888-5209      
United States, New York
Kings County Hopsital Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Jason Gonsky, MD    718-245-2847      
Coney Island Hospital Not yet recruiting
Brooklyn, New York, United States, 11235
Contact: Jack Burton, MD    718-616-3000      
Woodhull Hospital Not yet recruiting
Brooklyn, New York, United States
Contact: Stefan Balan, MD         
Principal Investigator: Stefan Balan, MD         
Memorial Sloan Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Tiffany Traina, MD    646-888-4558      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Tiffany Traina, MD    646-888-4558      
Queens Hospital Center Recruiting
Jamaica, New York, United States, 11432
Contact: Margaret Kemeny, MD         
Principal Investigator: Margaret Kemeny, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Tiffany Traina, MD    646-888-4558      
Contact: Ayca Gucalp, MD    646-888-4536      
Principal Investigator: Tiffany Traina, MD         
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Tiffany Traina, MD    646-888-4558      
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Nicholas Lamparella, DO         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Medivation, Inc.
Astellas Pharma Inc
Investigators
Principal Investigator: Tiffany Traina, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02750358     History of Changes
Other Study ID Numbers: 15-307
First Submitted: April 21, 2016
First Posted: April 25, 2016
Last Update Posted: September 18, 2017
Last Verified: September 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Enzalutamide
15-307

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases