18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Progression Free Survival (PFS)Primary· 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 t
Group
Value
95% CI
Everolimus
7.2
4.1 – 10.0
Number of Patients With Adverse Events (AEs) as a Measure of Safety and TolerabilitySecondary· 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.
Group
Value
95% CI
Everolimus
48
Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR).Secondary· 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.
Group
Value
95% CI
Everolimus
2
Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR)Secondary· 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).
Group
Value
95% CI
Everolimus
12
Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR)Secondary· 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 lesi
Group
Value
95% CI
Everolimus
8.8
1.8 – 11.8
Median Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Everolimus
26.7
16.3 – 26.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 20 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Everolimus
Serious: 15/48 (31%)
Deaths: 32/48
Serious adverse events (19 terms)
Reaction
System
Everolimus
Constipation
Gastrointestinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Cardiac failure congestive
Cardiac disorders
—
Esophagitis
Gastrointestinal disorders
—
Gastrointestinal hemorrhage
Gastrointestinal disorders
—
Non-Cardiac chest pain
General disorders
—
Pain
General disorders
—
Cholecystitis
Hepatobiliary disorders
—
Diverticulitis
Infections and infestations
—
Cellulitis
Infections and infestations
—
Gastroenteritis
Infections and infestations
—
Sepsis
Infections and infestations
—
Dehydration
Metabolism and nutrition disorders
—
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
· EARLY_PHASE1
· recruiting
NCT07318324 — Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
· Phase 1
· not yet recruiting
NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies
· Phase 2
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06832189 — EVR and EPO for Liver Transplant Tolerance
· Phase 1
· recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
· Phase 2
· recruiting
Other SCRI Development Innovations, LLC trials
Trials by the same sponsor.
NCT04699630 — A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer
· Phase 2
· completed
NCT04402138 — Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma
· Phase 2
· completed
NCT04200365 — A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
· Phase 2
· terminated
NCT04209725 — A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
· Phase 2
· terminated
NCT04361058 — Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide
· Phase 1
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SCRI Development Innovations, LLC
Last refreshed: 17 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02291913.