drugset / Trial / NCT01674140

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

NCT01674140

Phase 3 Active not recruiting 1939 enrolled SWOG Cancer Research Network National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 10 mg Oral
Background Anastrozole Other / unclassified Oral
Background Exemestane Small molecule Oral
Background Goserelin Other / unclassified Subcutaneous
Background Letrozole Other / unclassified Oral
Background Leuprolide Other / unclassified Subcutaneous
Background Tamoxifen Small molecule Oral

Indications