Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
|ClinicalTrials.gov Identifier: NCT00382070|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2006
Last Update Posted : May 5, 2017
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole Other: Placebo||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3966 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||October 2018|
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
- 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. ]
- Overall survival [ Time Frame: Time from randomization to any death ]
- Breast cancer-free interval [ Time Frame: Time from randomization to recurrence or contralateral second primary cancer ]
- Distant recurrence [ Time Frame: Time from randomization to distant recurrence of breast cancer. ]
- Osteoporotic-related fractures [ Time Frame: Incidence of osteoporotic-related fractures (Colles', hip, and spine). ]
- 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]) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382070
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|