A Phase 2 interventional study of Everolimus and Exemestane in Breast Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 8 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression. Everolimus, in combination with exemestane, has shown activity in endocrine-resistant disease. This study will evaluate the efficacy of Everolimus+ anti-estrogen therapy in patients with ER-positive metastatic breast cancer who have progressed after receiving anti-estrogen therapy.
This is a multi-centered, open-labeled, Phase II study on metastastic breast cancer (MBC). The patient population includes locally recurrent or MBC patients with cytologically or histologically confirmed hormone receptor-positive breast cancer who have demonstrated disease progression on prior anti-estrogen therapy or therapies. Investigators propose to evaluate the efficacy of Everolimus in patients with ER-positive (estrogen receptor-positive) metastatic breast cancer who have progressed on anti-estrogen therapy. Forty-six (46) patients are planned for enrollment in the trial.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 48 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
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Progressed on anti-estrogen therapy (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy) defined as:
Note: No washout for anti-estrogen therapy required. Anti-estrogen therapy does not have to be the last treatment prior to study entry.
HER2-negative breast cancer, defined as follows:
Exclusion Criteria:
NOTE: There are additional inclusion/exclusion criteria. The study center will determine patient eligibility and respond to any questions.
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.
Drug: Everolimus · Drug: Exemestane · Drug: Tamoxifen · Drug: Fulvestrant · Drug: Anastrozole · Drug: Letrozole · Drug: Toremifine
Also known as: Afinitor
Anti-estrogen therapy
Anti-estrogen therapy
Anti-estrogen therapy
Anti-estrogen therapy
Anti-estrogen therapy
Anti-estrogen therapy
Median Progression Free Survival (PFS)
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).
Time frame: up to 3 years
Number of Patients With Adverse Events (AEs) as a Measure of Safety and Tolerability
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.
Time frame: Up to 20 months
Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR).
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.
Time frame: every 8 weeks until discontinuation, up to 20 months
Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR)
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).
Time frame: Up to 20 months
Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR)
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.
Time frame: every 8 weeks until discontinuation, up to 20 months
Median Overall Survival (OS)
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.
Time frame: up to 3 years from first treatment
Between December 2014 to December 2015, 48 patients who had locally recurrent or metastatic breast cancer with cytologically or histologically confirmed hormone receptor-positive breast cancer who have demonstrated disease progression on prior anti-estrogen therapy. Study was closed after enrollment goal was reached.
| Milestone | Everolimus |
|---|---|
| Started | 48 |
| Completed | 0 |
| Not completed | 48 |
| Withdrew: Progressive disease | 32 |
| Withdrew: Adverse event | 11 |
| Withdrew: Death | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
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).
| months | Everolimus |
|---|---|
| Median Progression Free Survival (PFS) | 7.2 (4.1 to 10.0) |
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.
| Participants | Everolimus |
|---|---|
| Number of Patients With Adverse Events (AEs) as a Measure of Safety and Tolerability | 48 |
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.
| Participants | Everolimus |
|---|---|
| Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR). | 2 |
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).
| Participants | Everolimus |
|---|---|
| Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR) | 12 |
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.
| months | Everolimus |
|---|---|
| Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR) | 8.8 (1.8 to 11.8) |
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.
| months | Everolimus |
|---|---|
| Median Overall Survival (OS) | 26.7 (16.3 to 26.7) |
Collected over Up to 20 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Everolimus | 32/48 (66.7%) | 15/48 (31.3%) | 48/48 (100%) |
| Event | Everolimus |
|---|---|
| ConstipationGastrointestinal disorders | 2/48 |
| AnemiaBlood and lymphatic system disorders | 1/48 |
| Cardiac failure congestiveCardiac disorders | 1/48 |
| EsophagitisGastrointestinal disorders | 1/48 |
| Gastrointestinal hemorrhageGastrointestinal disorders | 1/48 |
| Non-Cardiac chest painGeneral disorders | 1/48 |
| PainGeneral disorders | 1/48 |
| CholecystitisHepatobiliary disorders | 1/48 |
| DiverticulitisInfections and infestations | 1/48 |
| CellulitisInfections and infestations | 1/48 |
| Event | Everolimus |
|---|---|
| FatigueGeneral disorders | 31/48 |
| NauseaGastrointestinal disorders | 18/48 |
| StomatitisGastrointestinal disorders | 15/48 |
| RashSkin and subcutaneous tissue disorders | 15/48 |
| Mucosal InflammationGeneral disorders | 13/48 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 13/48 |
| DiarrhoeaGastrointestinal disorders | 12/48 |
| HeadacheNervous system disorders | 11/48 |
| VomitingGastrointestinal disorders | 10/48 |
| Urinary Tract InfectionInfections and infestations | 9/48 |
All patients who received at least one dose of treatment.
| Age, Categorical(Participants) | Everolimus |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 19 |
| Age, Continuous(years) | Everolimus |
|---|---|
| Median | 62 (36 to 81) |
| Sex: Female, Male(Participants) | Everolimus |
|---|---|
| Female | 48 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Everolimus |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 40 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | Everolimus |
|---|---|
| United States | 48 |
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