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

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ClinicalTrials.gov Identifier: NCT01889238
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Intervention: Drug: Enzalutamide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Data reported based on primary analysis date (01 March 2015)

Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression (DP), intolerable adverse events (AEs) (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).

Participant Flow:   Overall Study
    Enzalutamide
STARTED   118 
COMPLETED   109 [1] 
NOT COMPLETED   9 
Treatment ongoing                9 
[1] DP, AE, death, treatment withdrawal were considered completed (defined in protocol).



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all enrolled participants who had positive androgen receptor (AR+) breast cancer as assessed by central review and received at least 1 dose of study drug.

Reporting Groups
  Description
Enzalutamide Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).

Baseline Measures
   Enzalutamide 
Overall Participants Analyzed 
[Units: Participants]
 118 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (12.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      118 100.0% 
Male      0   0.0% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population   [ Time Frame: Week 16 ]

2.  Primary:   Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population   [ Time Frame: Week 16 ]

3.  Secondary:   Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population   [ Time Frame: Week 24 ]

4.  Secondary:   Percentage of Participants With Clinical Benefit at Week 24: ITT Population   [ Time Frame: Week 24 ]

5.  Secondary:   Percentage of Participants With Best Objective Response: Evaluable Population   [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]

6.  Secondary:   Percentage of Participants With Best Objective Response: ITT Population   [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]

7.  Secondary:   Progression-Free Survival (PFS): Evaluable Population   [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]

8.  Secondary:   Progression-Free Survival: ITT Population   [ Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks) ]

9.  Other Pre-specified:   Trough Plasma Concentration of Enzalutamide and Its Metabolite,   [ Time Frame: Predose on Day 1 (Baseline), Week 9 and Week 17 ]

10.  Other Pre-specified:   Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 87 weeks ]

11.  Other Pre-specified:   Number of Participants With Study Drug Discontinuation Due to Adverse Events   [ Time Frame: Baseline up to 87 weeks ]

12.  Other Pre-specified:   Number of Participants With Grade 3 or Higher Adverse Events   [ Time Frame: Baseline up to 87 weeks ]

13.  Other Pre-specified:   Number of Participants With Clinically Significant Change From Baseline in Vital Signs   [ Time Frame: Baseline up to 87 weeks ]

14.  Other Pre-specified:   Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades   [ Time Frame: Baseline up to 87 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As per change in planned analysis, AR low population (all enrolled participants who had AR nuclear staining > 0%, < 10% assessed centrally) was not analyzed for efficacy and duration of response, time to response were not analyzed for any population


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_inquiries@pfizer.com



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
Results First Submitted: July 26, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018