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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Fulvestrant with Enzalutamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer|
|Actual Study Start Date :||July 6, 2017|
|Actual Primary Completion Date :||November 21, 2019|
|Actual Study Completion Date :||April 10, 2020|
Experimental: 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, in conjunction with Fulvestrant, PO daily.
Drug: 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.
- Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant [ Time Frame: 24 Weeks ]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.
- Number of Participants With Treatment-Emergent Adverse Events (Safety Profile) [ Time Frame: 24 Weeks ]The safety of the combination of enzalutamide with fulvestrant will be assessed according to CTCAE 4.03.
- Percent Progression Free at 24 Weeks [ Time Frame: Up to 24 Weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953860
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|Lone Tree Medical Center|
|Lone Tree, Colorado, United States, 80124|
|United States, Tennessee|
|West Cancer Center|
|Germantown, Tennessee, United States, 38138|
|Principal Investigator:||Anthony D Elias, MD||University of Colorado, Denver|