Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003140
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
1999-11-01
Brief Title:
Letrozole After Tamoxifen in Treating Women With Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Status:
COMPLETED
Status Verified Date:
2012-03
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 stimulate the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen
PURPOSE This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years
PURPOSE This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years
Detailed Description:
OBJECTIVES
Primary
Compare the disease-free survival and overall survival of postmenopausal women with primary breast cancer who have completed at least five years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen treated with letrozole or placebo
Secondary
Compare the incidence of contralateral breast cancer in patients treated with these regimens
Evaluate the long-term clinical and laboratory safety of letrozole in terms of lipid profile cardiovascular morbidity and mortality incidence of bone fractures change in bone density and common toxic effects in this patient population
Compare the quality of life of patients treated with these regimens Re-randomization
Primary
Compare disease-free survival of patients who after receiving at least 45 years of letrozole are re-randomized to receive an additional 5 years of letrozole vs placebo
Secondary
Determine whether common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic andor pharmacodynamic pathways for letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to receptor status positive vs unknown lymph node status negative vs positive vs unknown prior adjuvant chemotherapy yes vs no interval between last dose of aromatase inhibitor therapy and randomization 6 months vs 6 months-2 years and duration of prior tamoxifen use 0 years vs 2 years vs 2-45 years vs 45 years Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral letrozole once daily
Arm II Patients receive oral placebo once daily In both arms treatment continues for 5 years in the absence of disease progression or unacceptable toxicity Patients in arm II may then be offered oral letrozole once daily for up to 5 years
Quality of life is assessed at baseline at 6 months and then annually for 45 years
Double-blind re-randomization
Patients who complete 45 years of letrozole arm I and who did not experience recurrent disease or new primary breast cancer including ductal carcinoma in situ may participate in the double-blind placebo-controlled re-randomization portion of the study Patients are stratified according to lymph node status at enrollment negative vs positive vs unknown prior adjuvant chemotherapy yes vs no and interval between last dose of letrozole and re-randomization 6 months vs 6 months to 2 years Common genetic single nucleotide polymorphisms for genes encoding proteins involved in pharmacokinetic andor pharmacodynamic pathways for letrozole are analyzed in order to determine if these single nucleotide polymorphisms contribute to individual variation in toxicity and efficacy of letrozole therapy
Quality of life is assessed as during the first randomization
Patients are followed annually
PROJECTED ACCRUAL A total of 4700 patients will be accrued for this study
Primary
Compare the disease-free survival and overall survival of postmenopausal women with primary breast cancer who have completed at least five years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen treated with letrozole or placebo
Secondary
Compare the incidence of contralateral breast cancer in patients treated with these regimens
Evaluate the long-term clinical and laboratory safety of letrozole in terms of lipid profile cardiovascular morbidity and mortality incidence of bone fractures change in bone density and common toxic effects in this patient population
Compare the quality of life of patients treated with these regimens Re-randomization
Primary
Compare disease-free survival of patients who after receiving at least 45 years of letrozole are re-randomized to receive an additional 5 years of letrozole vs placebo
Secondary
Determine whether common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic andor pharmacodynamic pathways for letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to receptor status positive vs unknown lymph node status negative vs positive vs unknown prior adjuvant chemotherapy yes vs no interval between last dose of aromatase inhibitor therapy and randomization 6 months vs 6 months-2 years and duration of prior tamoxifen use 0 years vs 2 years vs 2-45 years vs 45 years Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral letrozole once daily
Arm II Patients receive oral placebo once daily In both arms treatment continues for 5 years in the absence of disease progression or unacceptable toxicity Patients in arm II may then be offered oral letrozole once daily for up to 5 years
Quality of life is assessed at baseline at 6 months and then annually for 45 years
Double-blind re-randomization
Patients who complete 45 years of letrozole arm I and who did not experience recurrent disease or new primary breast cancer including ductal carcinoma in situ may participate in the double-blind placebo-controlled re-randomization portion of the study Patients are stratified according to lymph node status at enrollment negative vs positive vs unknown prior adjuvant chemotherapy yes vs no and interval between last dose of letrozole and re-randomization 6 months vs 6 months to 2 years Common genetic single nucleotide polymorphisms for genes encoding proteins involved in pharmacokinetic andor pharmacodynamic pathways for letrozole are analyzed in order to determine if these single nucleotide polymorphisms contribute to individual variation in toxicity and efficacy of letrozole therapy
Quality of life is assessed as during the first randomization
Patients are followed annually
PROJECTED ACCRUAL A total of 4700 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 |
|---|---|---|---|
| CDR0000065921 | OTHER | PDQ | httpsreporternihgovquickSearchU10CA025224 |
| U10CA025224 | NIH | None | None |
| CAN-NCIC-MA17 | REGISTRY | None | None |
| CALGB-49805 | None | None | None |
| E-JMA17 | None | None | None |
| EORTC-10983 | None | None | None |
| IBCSG-BIG97-01 | None | None | None |
| NCCTG-JMA17 | None | None | None |
| SWOG-JMA17 | None | None | None |
| JRF-Vor-Int-10 | None | None | None |
| NCCTG-CAN-MA17 | None | None | None |
| SWOG-CAN-MA17 | None | None | None |