Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer|
- Disease-free survival [ Time Frame: Time from randomization to local recurrence following mastectomy or lumpectomy (IBTR), regional recurrence, distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Time from randomization to any death ] [ Designated as safety issue: No ]
- Breast cancer-free interval [ Time Frame: Time from randomization to recurrence or contralateral second primary cancer ] [ Designated as safety issue: No ]
- Distant recurrence [ Time Frame: Time from randomization to distant recurrence of breast cancer. ] [ Designated as safety issue: No ]
- Osteoporotic-related fractures [ Time Frame: Incidence of osteoporotic-related fractures (Colles', hip, and spine). ] [ Designated as safety issue: Yes ]
- Arterial thrombotic events [ Time Frame: Incidence of arterial thrombotic events (CTCAE v. 3.0 grades 3, 4, or 5 cardiac ischemia/infarction, CNS cerebrovascular ischemia, peripheral arterial ischemia, and visceral arterial ischemia [nonmyocardial]) ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Group 2 Letrozole
Patients receive oral letrozole once daily for up to 5 years.
Letrozole 2.5 mg taken orally once daily for 5 years
Placebo Comparator: Group 1 Placebo
Patients receive oral placebo once daily for up to 5 years.
Placebo tablet taken orally once daily for 5 years
- 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.
- 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.
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation, Inc.|