Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02953860|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : February 24, 2020
|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 :||December 2, 2019|
|Estimated Study Completion Date :||November 2021|
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 (complete and partial response plus stable disease for 24 weeks) of the combination of enzalutamide/fulvestrant.
- Incidence of 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.
- Overall Response Rate [ Time Frame: 24 Weeks ]Tumor response will be assessed using RECIST 1.1
- Progression-Free Survival (PFS) [ 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. PFS will be measured at 12 and 24 weeks.
- AR signaling in breast cancer tissue in the tumor biopsies [ Time Frame: 24 Weeks ]To obtain serial biopsies of breast cancer pretreatment, during treatment and at time of tumor progression in order to determine the extent of AR expression and signaling in breast tissue, to evaluate the effect of enzalutamide on the tumor, and to evaluate the relationship of these effects on clinical outcomes.
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|