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Trial record 1 of 1 for:    NCT02953860
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Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT02953860
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Fulvestrant with Enzalutamide
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fulvestrant With Enzalutamide
Hide Arm/Group Description

500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.

Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.

Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Fulvestrant With Enzalutamide
Hide Arm/Group Description

500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.

Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
age 18 and up
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
61
(46 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
32
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   9.4%
White
27
  84.4%
More than one race
1
   3.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
 100.0%
1.Primary Outcome
Title Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant
Hide Description To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Fulvestrant With Enzalutamide
Hide Arm/Group Description:

500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.

Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.

Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
7
  21.9%
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
Hide Description The safety of the combination of enzalutamide with fulvestrant will be assessed according to CTCAE 4.03.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
all eligible patients
Arm/Group Title Fulvestrant With Enzalutamide
Hide Arm/Group Description:

500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.

Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
fatigue 17
nausea 16
vomiting 9
constipation 10
headache 11
diarrhea 7
cognitive dysfunction 5
3.Secondary Outcome
Title Percent Progression Free at 24 Weeks
Hide Description PFS is defined as the time from the first day of enzalutamide treatment (Study Day 1) until documented disease progression or death on study, whichever occurs first. Percent (%) progression free at 24 weeks is the number of patients without disease progression after 24 weeks follow-up.
Time Frame Up to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
all eligible patients
Arm/Group Title Fulvestrant With Enzalutamide
Hide Arm/Group Description:

500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.

Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.

Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
7
  21.9%
Time Frame AEs collected during treatment (which lasted up to a year)
Adverse Event Reporting Description CTCAE 4.0 Collected with each monthly visit, patients kept diary.
 
Arm/Group Title Fulvestrant With Enzalutamide
Hide Arm/Group Description

500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.

Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.

All-Cause Mortality
Fulvestrant With Enzalutamide
Affected / at Risk (%)
Total   0/32 (0.00%)    
Hide Serious Adverse Events
Fulvestrant With Enzalutamide
Affected / at Risk (%) # Events
Total   2/32 (6.25%)    
Cardiac disorders   
myocardial infarction  1 [1]  1/32 (3.13%)  1
Hepatobiliary disorders   
cholecystitis  1 [2]  1/32 (3.13%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
Felt not to be related to treatment. Unrelated to fulvestrant unlikely related to enzalutamide
[2]
unrelated to fulvestrant and enzalutamide
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fulvestrant With Enzalutamide
Affected / at Risk (%) # Events
Total   17/32 (53.13%)    
Endocrine disorders   
Hot Flashes  1  6/32 (18.75%)  6
Gastrointestinal disorders   
nausea  1  16/32 (50.00%)  16
vomiting  1  9/32 (28.13%)  9
constipation  1  10/32 (31.25%)  10
anorexia  1  9/32 (28.13%)  9
General disorders   
Fatigue  1  17/32 (53.13%)  17
Musculoskeletal and connective tissue disorders   
achiness  1  14/32 (43.75%)  14
Nervous system disorders   
insomnia  1  6/32 (18.75%)  6
headache  1  11/32 (34.38%)  11
cognitive dysfunction  1  5/32 (15.63%)  5
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
limited size of trial not randomized heavily pretreated somewhat heterogeneous population
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Anthony Elias
Organization: University of Colorado
Phone: 720-848-0347
EMail: anthony.elias@cuanschutz.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02953860    
Other Study ID Numbers: 16-1001.cc
First Submitted: November 1, 2016
First Posted: November 3, 2016
Results First Submitted: March 12, 2021
Results First Posted: May 14, 2021
Last Update Posted: May 14, 2021