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Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT02007512
Recruitment Status : Active, not recruiting
First Posted : December 10, 2013
Results First Posted : February 6, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Enzalutamide
Drug: exemestane
Drug: Placebo (for 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
This was a phase 2, randomized, double blind, placebo-controlled study. The results disclosed in this draft were based on the data collected till 23 Sep 2016.

Reporting Groups
  Description
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Cohort 1: Placebo + Exemestane 25 mg Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Cohort 2: Placebo + Exemestane 25 mg Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.

Participant Flow for 2 periods

Period 1:   Double Blind Treatment Period
    Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg   Cohort 1: Placebo + Exemestane 25 mg   Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg   Cohort 2: Placebo + Exemestane 25 mg
STARTED   63   64   60   60 
Treated   62   63   60   60 
COMPLETED   0   0   0   0 
NOT COMPLETED   63   64   60   60 
Adverse Event                4                2                6                2 
Death                1                0                0                0 
Disease progression                44                49                45                51 
Withdrawal by Subject                4                2                3                3 
Protocol Violation                0                0                0                1 
Other                0                0                1                2 
Ongoing as of data cutoff (23 Sep 2016)                10                11                5                1 

Period 2:   Open Label Treatment Period
    Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg   Cohort 1: Placebo + Exemestane 25 mg   Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg   Cohort 2: Placebo + Exemestane 25 mg
STARTED   0   21 [1]   0   12 [2] 
COMPLETED   0   0   0   0 
NOT COMPLETED   0   21   0   12 
Adverse Event                0                1                0                0 
Other                0                0                0                1 
Disease progression                0                17                0                11 
Ongoing as of data cutoff (23 Sep 2016)                0                3                0                0 
[1] Of the participants with disease progression in double blind period, 21 entered open label period.
[2] Of the participants with disease progression in double blind period, 12 entered open label period.



  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 the participants randomly assigned to double-blind study treatment.

Reporting Groups
  Description
Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg Participants with no previous hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Cohort 1: Placebo + Exemestane 25 mg Participants with no previous hormonal treatment for advanced breast cancer received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg Participants with previous disease progression following hormonal treatment for advanced breast cancer, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Cohort 2: Placebo + Exemestane 25 mg Participants with previous disease progression following hormonal treatment for advanced breast cancer, received placebo matched to enzalutamide along with exemestane 25 mg, orally, once daily in double blind treatment period until disease progression or permanent treatment discontinuation. Eligible participants with disease progression in double blind period, on their discretion, received enzalutamide 160 mg along with exemestane 50 mg, orally, once daily up to disease progression in open label treatment period. Participants were followed-up until 30 days after last dose of study drug, death, or before initiation of a new antitumor treatment, whichever occurred first.
Total Total of all reporting groups

Baseline Measures
   Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg   Cohort 1: Placebo + Exemestane 25 mg   Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg   Cohort 2: Placebo + Exemestane 25 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   64   60   60   247 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      42  66.7%      32  50.0%      37  61.7%      40  66.7%      151  61.1% 
>=65 years      21  33.3%      32  50.0%      23  38.3%      20  33.3%      96  38.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      63 100.0%      64 100.0%      60 100.0%      60 100.0%      247 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS): Intent-to-Treat (ITT) Population   [ Time Frame: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]

2.  Primary:   Progression Free Survival (PFS): Diagnostic Positive (DX+) Population   [ Time Frame: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]

3.  Secondary:   Clinical Benefit Rate-24 (CBR-24)   [ Time Frame: From randomization up to 3 years ]

4.  Secondary:   Best Objective Response Rate   [ Time Frame: From randomization until CR or PR, whichever occurred first (up to 3 years) ]

5.  Secondary:   Duration of Objective Response   [ Time Frame: From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]

6.  Secondary:   Time to Response   [ Time Frame: From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years) ]

7.  Secondary:   Time to Progression   [ Time Frame: From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years) ]

8.  Secondary:   Progression Free Survival (PFS) at 6 Months   [ Time Frame: Month 6 ]

9.  Secondary:   Concentration Versus Time Summary of Enzalutamide   [ Time Frame: Predose on Day 29, 57 and 113 ]

10.  Secondary:   Concentration Versus Time Summary of Exemestane   [ Time Frame: Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169 ]

11.  Secondary:   Concentration Versus Time Summary of N-desmethyl Enzalutamide   [ Time Frame: Predose on Day 29, 57 and 113 ]

12.  Other Pre-specified:   Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC)   [ Time Frame: Day 1, 29, 57, 113 and 169 ]

13.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]

14.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]

15.  Other Pre-specified:   Number of Participants With Clinically Significant Vital Sign Abnormalities   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]

16.  Other Pre-specified:   Number of Participants With Clinically Significant Laboratory Abnormalities   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]

17.  Other Pre-specified:   European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30)   [ Time Frame: Month 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

18.  Other Pre-specified:   European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23)   [ Time Frame: Month 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: NCT02007512     History of Changes
Other Study ID Numbers: MDV3100-12
2013-002717-35 ( EudraCT Number )
C3431008 ( Other Identifier: Alias Study Number )
First Submitted: December 3, 2013
First Posted: December 10, 2013
Results First Submitted: September 21, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 12, 2018