CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,939 enrolled
Drug / intervention
anastrozole +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01674140
NCT01674140Phase 3Active

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

SWOG Cancer Research Network·interventional·Posted Aug 28, 2012·Updated Feb 10, 2026

In Brief

A Phase 3 clinical trial evaluating anastrozole, everolimus, and 6 other interventions for Breast Cancer. Active but no longer recruiting, targeting 1,939 participants across 1,459 sites in 2 countries.

Detailed Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesPuerto Rico, United States

Timeline

Phase 3Active
201320142015201620172018201920202021202220232024202520262027202820292030
First PostedAug 28, 2012
Enrollment StartSep 12, 2013
Primary CompletionDec 1, 2022
Study CompletionJan 1, 2030
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 13.8 years ago

Interventions

anastrozoledrug

Given orally

everolimusdrug

Given PO

exemestanedrug

Given orally

goserelin acetatedrug

Given subcutaneously or intramuscularly

letrozoledrug

Given orally

leuprolide acetatedrug

Given subcutaneously or intramuscularly

tamoxifen citratedrug

Given PO

placeboother

Given PO