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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• anastrozole — DRUG
  Given orally
• everolimus — DRUG
  Given PO
• exemestane — DRUG
  Given orally
• goserelin acetate — DRUG
  Given subcutaneously or intramuscularly
• letrozole — DRUG
  Given orally
• leuprolide acetate — DRUG
  Given subcutaneously or intramuscularly
• tamoxifen citrate — DRUG
  Given PO
• placebo — OTHER
  Given PO

Study Details

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.

Key Dates

First listed

Aug 28, 2012

Start date

Sep 12, 2013

Status verified

Jan 2026

Primary completion

Dec 1, 2022

Completion

Jan 31, 2030

Study Design

Enrollment

1,939 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Arm I
  Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or an aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II
  Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Invasive Disease-Free Survival (IDFS) [ Time Frame: Up to 5 years post registration ]

Locations (1455)