Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02291913|
Recruitment Status : Completed
First Posted : November 17, 2014
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
|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 :||December 18, 2014|
|Actual Primary Completion Date :||January 31, 2019|
|Actual Study Completion Date :||January 31, 2019|
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
- Median Progression Free Survival (PFS) [ Time Frame: up to 3 years ]PFS is defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, or death on study. Participants who are alive and free from disease progression will be censored at the date of last radiologic tumor assessment. Participants who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. Participants who do not have a post-baseline tumor assessment will be censored at the date of first treatment (Day 1).
- Number of Patients With Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 20 months ]Assessments were made through analysis of the reported incidence of treatment-emergent AEs. All participants who received at least one dose of protocol treatment were followed for safety. Adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
- Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR). [ Time Frame: every 8 weeks until discontinuation, up to 20 months ]Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST version 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.
- Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR) [ Time Frame: Up to 20 months ]The proportion of patients with Complete Response (CR) or Partial Response (PR) or 6 months or more of Stable Disease (SD). A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters. SD is not meeting the criteria for PR or a 20% increase in target lesions called Progressive Disease (PD).
- Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR) [ Time Frame: every 8 weeks until discontinuation, up to 20 months ]Only those patients who achieved Complete Response or Partial Response will be included in the summaries of DOR. DOR is defined as time from first date of response of CR or PR to disease progression or death as defined by RECIST v1.1 criteria. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.
- Median Overall Survival (OS) [ Time Frame: up to 3 years from first treatment ]Defined as the time from date of first study treatment to date of death due to any cause. Patients who are alive will be censored at the date of last known date alive.
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): 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|