Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
|ClinicalTrials.gov Identifier: NCT02291913|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2014
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Everolimus Drug: Exemestane Drug: Tamoxifen Drug: Fulvestrant Drug: Anastrozole Drug: Letrozole Drug: Toremifine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer|
|Actual Study Start Date :||January 7, 2015|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses.
Other Name: Afinitor
- Progression Free Survival (PFS) [ Time Frame: up to 3 years ]All patients who received at least 1 cycle of study treatment and had at least 1 post-baseline assessment will be evaluable. PFS defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 criteria, or death on study.
- Number of patients with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: approximately 1 year from first treatment ]Assessments will be made through analysis of the reported incidence of treatment-emergent AEs.
- Overall Response Rate (ORR) [ Time Frame: every 8 weeks until discontinuation, estimated 1 year from first treatment ]The proportion of patients with observed complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
- Clinical Benefit Rate (CBR) [ Time Frame: approximately 1 year from first treatment ]The proportion of patients with CR + PR + Stable Disease (SD) x 6 months
- Duration of Response (DOR) [ Time Frame: every 8 weeks until discontinuation, estimated 1 year from first treatment ]Defined as time from first date of response (CR or PR) to disease progression or death as defined by RECIST v1.1 criteria.
- Overall Survival [ Time Frame: up to 3 years from first treatment ]Defined as from Day 1 of study drug administration to date of death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291913
|United States, Florida|
|Florida Cancer Specialists-South|
|Fort Myers, Florida, United States, 33916|
|Memorial Cancer Center|
|Hollywood, Florida, United States, 33021|
|Woodlands Medical Specialists|
|Pensacola, Florida, United States, 32503|
|Florida Cancer Specialists-East|
|West Palm Beach, Florida, United States, 33401|
|United States, Indiana|
|Hope Cancer Center|
|Terre Haute, Indiana, United States, 47802|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Center for Cancer and Blood Disorders|
|Fort Worth, Texas, United States, 76104|
|Study Chair:||Denise A. Yardley, MD||SCRI Development Innovations, LLC|