Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
- Registration Number
- NCT00382070
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine whether or not prolonged adjuvant hormonal therapy comprising letrozole vs placebo will improve disease-free survival of postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive breast cancer who have completed 5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a combination of up to 3 years of tamoxifen citrate followed by an AI.
* Compare the disease-free survival of patients treated with these regimens.
Secondary
* Compare overall survival of patients treated with these regimens.
* Compare breast cancer-free interval of patients treated with these regimens.
* Compare distant recurrence in patients treated with these regimens.
* Compare the incidence of osteoporotic-related fractures (e.g., Colles', hip, and spine) in these patients treated with these regimens.
* Compare the incidence of arterial thrombotic events in patients treated with these regimens.
OUTLINE: This is a double-blind, multicenter, placebo-controlled, randomized study. Patients are stratified according to pathologic nodal status (negative vs positive), adjuvant tamoxifen citrate therapy (yes vs no), and lowest bone mineral density T score for lumbosacral spine, total hip, or femoral neck (\> -2.0 vs ≤ -2.0 standard deviation). Patients are randomized to 1 of 2 treatment arms.
* Group I: Patients receive oral placebo once daily.
* Group II: Patients receive oral letrozole once daily.
In both arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 3,840 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 3966
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Placebo Placebo Patients receive oral placebo once daily for up to 5 years. Group 2 Letrozole Letrozole Patients receive oral letrozole once daily for up to 5 years.
- Primary Outcome Measures
Name Time Method Disease-free Survival 7 years. Percentage of patients free from DFS events. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer.
- Secondary Outcome Measures
Name Time Method Breast Cancer-free Interval 7 years Cumulative incidence of breast-cancer-free interval events. BCFI events include local-regional recurrence, distant recurrence or contralateral breast cancer as a first event.
Arterial Thrombotic Events 7 years Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events \[cerebrovascular event, arterial insufficiency\]).
Overall Survival 7 years Percentage of patients alive
Osteoporotic-related Fractures 7 years Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures
Distant Recurrence 7 years Cumulative incidence of distant recurrences.
Trial Locations
- Locations (800)
Regional Medical Center
🇺🇸Anniston, Alabama, United States
Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Scroll for more (790 remaining)Regional Medical Center🇺🇸Anniston, Alabama, United States