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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

NCT01674140 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1939

Last updated 2026-02-10

Study results available
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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.

Conditions

Interventions

DRUG

anastrozole

Given orally

DRUG

everolimus

Given PO

DRUG

exemestane

Given orally

DRUG

goserelin acetate

Given subcutaneously or intramuscularly

DRUG

letrozole

Given orally

DRUG

leuprolide acetate

Given subcutaneously or intramuscularly

DRUG

tamoxifen citrate

Given PO

OTHER

placebo

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Mariana Chavez-MacGregor, MD, MSc · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-12
Primary Completion
2022-12-01
Completion
2030-01-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674140 on ClinicalTrials.gov