S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT01674140
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
- Detailed Description
OBJECTIVES:
Primary
* To compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer.
Secondary
* To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population.
* To evaluate the safety, toxicities, and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and to compare it with standard adjuvant endocrine therapy plus placebo in this patient population.
* To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors.
* To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population.
* To collect specimens in order to evaluate biomarkers of therapeutic efficacy. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to risk level (node-negative and recurrence score \[RS\] \> 25 in the primary tumor, and a tumor measuring ≥ 2 cm in greatest diameter treated with adjuvant therapy vs 1-3 positive lymph nodes and RS \> 25 treated with adjuvant therapy vs ≥ 4 positive lymph nodes \[any RS value\] treated with adjuvant therapy vs ≥ 4 positive lymph nodes \[any RS value\] prior to or after neoadjuvant chemotherapy). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
* 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.
NOTE: \*Men receive tamoxifen citrate PO for 5 years.
NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
Blood and tissue samples are collected for biomarker studies.
After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 10 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1939
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II leuprolide acetate 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. Arm II goserelin acetate 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. Arm I goserelin acetate 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. Arm I tamoxifen citrate 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. Arm I placebo 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. Arm I leuprolide acetate 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. Arm II tamoxifen citrate 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. Arm II anastrozole 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. Arm II everolimus 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. Arm I anastrozole 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. Arm I exemestane 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. Arm II exemestane 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. Arm I letrozole 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. Arm II letrozole 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 Measures
Name Time Method Invasive Disease-Free Survival (IDFS) Up to 5 years post registration Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. The results were presented as 5-year IDFS estimate.
- Secondary Outcome Measures
Name Time Method Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years. Every 6 weeks while on protocol therapy. Adverse events (AEs) that occurred during follow up after protocol treatment were reported as late AEs, for every 6 months for the first 2 years and then yearly until 10 years after registration. Toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Overall Survival (OS) 5 years after last accrual Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The results were presented as 5-year OS estimate.
Distant Recurrence-Free Survival (DRFS) 5 years after last accrual Time from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. The results were presented as 5-year DRFS estimate.
Trial Locations
- Locations (1448)
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
Alaska Regional Hospital
🇺🇸Anchorage, Alaska, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Anchorage Oncology Centre
🇺🇸Anchorage, Alaska, United States
Katmai Oncology Group
🇺🇸Anchorage, Alaska, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
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