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A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT02091960
Recruitment Status : Active, not recruiting
First Posted : March 19, 2014
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HER2 Amplified
Advanced Breast Cancer
Human Epidermal Growth Factor Receptor 2 (HER2)
Interventions: Drug: Enzalutamide
Drug: Trastuzumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 35 clinical sites in Belgium, Canada, Italy, Spain, the United Kingdom and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

This study enrolled women with human epidermal growth factor receptor 2 positive (HER2+) and androgen receptor positive (AR+) metastatic or locally advanced breast cancer who progressed on anti-HER2 therapy in the metastatic or advanced setting.

The study is ongoing, results are reported as of the data cut off date of 28 February 2017.


Reporting Groups
  Description
Enzalutamide + Trastuzumab Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.

Participant Flow:   Overall Study
    Enzalutamide + Trastuzumab
STARTED   103 
Received Treatment   103 
COMPLETED   52 [1] 
NOT COMPLETED   51 
Death                7 
Withdrawal by Subject                1 
Miscellaneous Reasons                31 
On Study at Data Cut-off                12 
[1] Completed indicates participants with disease progression



  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.
No text entered.

Reporting Groups
  Description
Enzalutamide + Trastuzumab Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.

Baseline Measures
   Enzalutamide + Trastuzumab 
Overall Participants Analyzed 
[Units: Participants]
 103 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   103 
   59.3  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   103 
Female      103 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   103 
Hispanic or Latino      5   4.9% 
Not Hispanic or Latino      98  95.1% 
Unknown or Not Reported      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Race   
Participants Analyzed   103 
White      90  87.4% 
Black or African American      8   7.8% 
Asian      3   2.9% 
American Indian or Alaskan Native      0   0.0% 
Native Hawaiian or other Pacific Islander      1   1.0% 
Other      1   1.0% 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   103 
Grade 0      51  49.5% 
Grade 1      51  49.5% 
Missing      1   1.0% 
[1] A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
Time from Initial Diagnosis of Primary Cancer to Enrollment [1] 
[Units: Days]
Median (Full Range)
 
Participants Analyzed   95 
   1199 
 (30 to 4713) 
[1] Participants for whom data were available
Histopathology at Diagnosis 
[Units: Participants]
Count of Participants
 
Participants Analyzed   103 
Ductal      73  70.9% 
Inflammatory      5   4.9% 
Intraductal      6   5.8% 
Lobular      6   5.8% 
Mixed      1   1.0% 
Not otherwise specified      1   1.0% 
Other      5   4.9% 
Unknown      6   5.8% 
Anatomic Stage [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   103 
Stage 0      3   2.9% 
Stage IA      6   5.8% 
Stage IB      1   1.0% 
Stage IIA      14  13.6% 
Stage IIB      12  11.7% 
Stage IIIA      5   4.9% 
Stage IIIB      7   6.8% 
Stage IIIC      7   6.8% 
Stage IV      28  27.2% 
Unknown      20  19.4% 
[1]

Breast cancer staging is based on size of the tumor, whether cancer cells have spread to lymph nodes or to other parts of the body, how aggressive the cells appear when viewed under a microscope, whether the cancer cells have receptors for estrogen and progesterone or have a gene mutation that causes them to make excess HER2 protein, and the results of gene expression profiling tests.

The stages of breast cancer range from 0 to IV, where Stage 0 is noninvasive or contained within the milk ducts and Stage IV breast cancer, also called metastatic, has spread to other areas of the body.



  Outcome Measures

1.  Primary:   Clinical Benefit Rate (CBR)   [ Time Frame: Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days. ]

2.  Secondary:   Overall Response Rate at Week 24   [ Time Frame: 24 weeks ]

3.  Secondary:   Best Overall Response Rate   [ Time Frame: Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days. ]

4.  Secondary:   Progression-free Survival   [ Time Frame: From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days. ]

5.  Secondary:   Time to Progression   [ Time Frame: From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days. ]

6.  Secondary:   Duration of Response   [ Time Frame: Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days. ]

7.  Secondary:   Time to Response   [ Time Frame: From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days. ]

8.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever was first; median duration of treatment was 70 days, and the maximum was 660 days. ]


  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: Clinical Trial Disclosure
Organization: Astellas Global Development, Inc. (APGD)
phone: 800-888-7704 ext 5473
e-mail: astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT02091960     History of Changes
Other Study ID Numbers: 9785-CL-1121
2013-000093-29 ( EudraCT Number )
First Submitted: March 18, 2014
First Posted: March 19, 2014
Results First Submitted: February 27, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018