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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medivation, Inc.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01889238
First received: June 26, 2013
Last updated: June 19, 2014
Last verified: June 2014

June 26, 2013
June 19, 2014
May 2013
May 2015   (final data collection date for primary outcome measure)
Clinical Benefit Rate [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01889238 on ClinicalTrials.gov Archive Site
  • Clinical Benefit Rate [ Time Frame: ≥ 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Ctrough [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
    To assess the pharmacokinetics (PK) of enzalutamide and its active metabolite N desmethyl enzalutamide
Same as current
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Androgen Receptor Expression [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
 
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Drug: Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily
Other Names:
  • Xtandi®
  • MDV3100
Experimental: Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
Intervention: Drug: Enzalutamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
95
May 2016
May 2015   (final data collection date for primary outcome measure)

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 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.
Female
18 Years and older
No
Contact: Jane Dennison 855-349-1891 breastcancertrials@medivation.com
United States,   Belgium,   Canada,   Ireland,   Italy,   Spain,   United Kingdom
 
NCT01889238
MDV3100-11, 2013 000698 57
Not Provided
Medivation, Inc.
Medivation, Inc.
Astellas Pharma Inc
Study Chair: Amy Peterson, MD Medivation, Inc.
Medivation, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP