Study of Combined Fulvestrant and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure (BRE-43)
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|ClinicalTrials.gov Identifier: NCT00570921|
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : December 31, 2014
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Everolimus Drug: Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Combined Fulvestrant (Faslodex) and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||January 2015|
Experimental: Fulvestrant + Everolimus
Fulvestrant + Everolimus
Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.
Everolimus tablets, two-5 mg tablets a day
Other Name: RAD001
intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter
Other Name: Faslodex
- Time to Progression [ Time Frame: Duration of time start of treatment to time of documented progression or death ]
- Objective Response Rates [ Time Frame: Evaluated 60 days after therapy start ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 [ Time Frame: Duration of response or stable disease for 24 weeks or more ]Clinical benefit rate is defined as a complete response, partial response, or stable disease (CR, PR, SD) by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks or more.
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): NCT00570921
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Mara Chambers, M.D.||University of Kentucky|