Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382070
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2006-09-26
Brief Title:
Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 eg 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 -20 vs -20 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 3840 patients will be accrued for this study
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 andor 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 eg 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 -20 vs -20 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 3840 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA012027 | NIH | None | httpsreporternihgovquickSearchU10CA012027 |