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Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01889238
First Posted: June 28, 2013
Last Update Posted: August 8, 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. Read our disclaimer for details.
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
  Purpose
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.

Condition Intervention Phase
Advanced, Androgen Receptor Positive Triple Negative Breast Cancer Drug: Enzalutamide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-arm, Open-label, Multicenter Study Of The Clinical Activity And Safety Of Enzalutamide In Patients With Advanced, Androgen Receptor-positive, Triple-negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: ≥ 16 weeks ]
    To determine clinical benefit rate, defined as the proportion of evaluable patients with androgen receptor positive (AR+), triple negative breast cancer (TNBC) with a best response of complete response (CR), partial response (PR), or stable disease (SD) ≥ 16 weeks.


Secondary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: ≥ 24 weeks ]
    To determine clinical benefit rate, defined as the proportion of evaluable patients with a best response of Complete Response, Partial Response, or Stable Disease ≥ 24 weeks;

  • Best Objective Response Rate [ Time Frame: ≥ 16 weeks ]
  • Duration of Response [ Time Frame: ≥ 16 weeks ]
  • Time to Response [ Time Frame: ≥ 16 weeks ]
  • Progression Free Survival (PFS) [ Time Frame: ≥ 16 weeks ]
  • Pharmacokinetics - Ctrough (predose plasma concentration) [ Time Frame: ≥ 16 weeks ]
    To assess the pharmacokinetics (PK) of enzalutamide and its active metabolite N desmethyl enzalutamide


Other Outcome Measures:
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ]
  • Androgen Receptor Expression [ Time Frame: ≥ 16 weeks ]
    To determine the extent of androgen receptor (AR) expression and signaling in breast tissue and to evaluate the relationship of this expression with enzalutamide effects on circulating tumor biomarkers, circulating hormones, and clinical outcomes.


Enrollment: 118
Actual Study Start Date: June 12, 2013
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: March 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
Drug: Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily
Other Names:
  • Xtandi®
  • MDV3100

  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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women at least 18 years of age;
  • Advanced AR+ TNBC;
  • Availability of a representative tumor specimen:
  • Either measurable disease or bone only nonmeasurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Any severe concurrent disease, infection, or comorbid condition;
  • Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
  • Current or previously treated brain metastasis or active leptomeningeal disease;
  • Current hormone replacement therapy;
  • Local palliative radiation therapy within 7 days before day 1;
  • History of another invasive cancer within 5 years of day 1;
  • Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
  • Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Active gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks before day 1;
  • Treatment with any commercially available anticancer agent within 14 days before day 1;
  • Treatment with any investigational agent within 2 weeks before day 1;
  • Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
  • Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
  • 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): NCT01889238


  Show 120 Study Locations
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Chair: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01889238     History of Changes
Other Study ID Numbers: MDV3100-11
2013-000698-57 ( EudraCT Number )
C3431007 ( Other Identifier: Alias Study Number )
First Submitted: June 26, 2013
First Posted: June 28, 2013
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Pfizer:
breast cancer
triple negative
androgen receptor positive

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs