Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

Phase 3

Completed

Brief Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.

Detailed Description: OBJECTIVES:

Primary

* Compare the disease-free survival (DFS) of postmenopausal women treated with continuous letrozole for 5 years vs intermittent letrozole over a 5-year period.

Secondary

* Compare overall survival of patients treated with these two regimens.

* Compare distant DFS of these patients.

* Compare breast cancer-free interval of these patients.

* Compare sites of first DFS failure in these patients.

* Compare second (nonbreast) malignancies in these patients.

* Compare deaths without prior cancer events in these patients.

* Compare adverse events resulting from these two regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and type of prior endocrine therapy (selective estrogen receptor modulators \[SERMs\] alone vs aromatase inhibitors \[AIs\] alone vs both SERMs and AIs each for at least 1 month). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral letrozole daily for 5 years.

* Arm II: Patients receive oral letrozole daily for the first 9 months of years 1 through 4, followed by 12 months in year 5.

After completion of study therapy, patients are followed annually.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Continuous letrozole	Letrozole	Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)
Intermittent letrozole	Letrozole	Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months

Primary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	5-year estimates, reported at a median follow-up of 60 months	Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5-year estimates, reported at a median follow-up of 60 months	Duration of time from randomization to death from any cause, or was censored at the date last known alive. (Note, for patients who withdrew consent or were lost to follow-up but follow-up for survival was possible through hospital or registry records, OS was censored at the date last known alive rather than date of last follow-up/withdrawn consent).
Distant Recurrence-free Interval (DRFI)	5-year estimates, reported at a median follow-up of 60 months	Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.\* \*This endpoint replaced DDFS, which was specified in the protocol
Breast Cancer-free Interval	5-year estimates, reported at a median follow-up of 60 months	Duration of time from randomization to the first indication of the following events: invasive breast recurrence at local, regional or distant sites; a new invasive cancer in the contralateral breast (second non-breast malignancies are ignored). In the absence of an event, BCFI was censored at the date of last follow-up visit or date of death without prior breast cancer event.

Locations (163): Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Faulkner Hospital
🇺🇸
Boston, Massachusetts, United States
Armidale Hospital
🇦🇺
Armidale, New South Wales, Australia
Bankstown - Lidcombe Hospital
🇦🇺
Bankstown, New South Wales, Australia
Southern Highlands Cancer Center
🇦🇺
Bowral, New South Wales, Australia
Concord Repatriation General Hospital
🇦🇺
Concord, New South Wales, Australia
Breast Center
🇨🇭
Zurich, Switzerland
Port Mcquarie Base Hospital
🇦🇺
Port Macquarie, New South Wales, Australia
Prince of Wales Private Hospital
🇦🇺
Randwick, New South Wales, Australia
Tamworth Base Hospital
🇦🇺
Tamworth, New South Wales, Australia
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Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States