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Study 15 of 223 for search of: | United States, Alaska |
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Sponsors and Collaborators: |
National Surgical Adjuvant Breast and Bowel Project (NSABP) National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00382070 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: letrozole Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
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 |
Estimated Enrollment: | 3840 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral letrozole once daily for up to 5 years.
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Drug: letrozole
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo once daily for up to 5 years.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
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.
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 3,840 patients will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive carcinoma of the breast by core needle or final pathological evaluation of the surgical specimen
Received adjuvant hormonal therapy after breast cancer diagnosis for a duration of 57-63 months from the first dose (regardless of the number of missed doses) with 1 of the following:
Combination of up to 3 years of tamoxifen citrate followed by an AI for a total of 5 years
Must have undergone a bilateral mammogram within the past year (unilateral if patient had a mastectomy)
Must have undergone a lumpectomy with axillary nodal staging followed by breast radiotherapy OR a total mastectomy with axillary nodal staging
Estrogen receptor (ER)-positive and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
Postmenopausal as defined by any of the following criteria:
Cholesterol ≤ grade 1 (with or without cholesterol-lowering therapy) meeting 1 of the following criteria:
Criteria must be met within the past year if patient has any of the following:
History of ≥ 1 of the following risk factors for cardiovascular events:
No other prior malignancy within the past 5 years except for the following:
PRIOR CONCURRENT THERAPY:
No other concurrent hormonal therapy, including any of the following:
Estradiol acetate
Study Chair: | Terry Mamounas, MD, MPH, FACS | Aultman Cancer Center at Aultman Hospital |
Study ID Numbers: | CDR0000502263, NSABP-B-42 |
Study First Received: | September 26, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00382070 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Letrozole Tamoxifen Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |