Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066573
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2003-08-06
Brief Title:
Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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 exemestane or anastrozole may fight breast cancer by reducing the production of estrogen It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer
PURPOSE This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer
PURPOSE This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the event-free survival of postmenopausal women with receptor-positive primary breast cancer when treated with exemestane vs anastrozole
Secondary
Compare the overall survival of patients treated with these regimens
Compare the time to distant recurrence in patients treated with these regimens
Compare the incidence of new primary contralateral breast cancer in patients treated with these regimens
Compare the incidence of all clinical fractures specifically hip and vertebral fractures in patients treated with these regimens
Compare cardiovascular morbidity and mortality ie significant coronary heart disease which includes myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft fatal and nonfatal strokes and all vascular deaths in patients treated with these regimens
Correlate therapy induced changes in breast density with plasma hormones and growth factors drug levels of exemestane and anastrozole genetic variation and breast cancer recurrence or contralateral events in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to lymph node status at diagnosis negative vs positive vs unknown prior adjuvant chemotherapy yes vs no and herceptin use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral exemestane 25 mg once daily for 5 years
Arm II Patients receive oral anastrozole 1 mg once daily for 5 years In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months during the first year of study participation and annually thereafter
PROJECTED ACCRUAL A total of 6840 patients will be accrued for this study
Primary
Compare the event-free survival of postmenopausal women with receptor-positive primary breast cancer when treated with exemestane vs anastrozole
Secondary
Compare the overall survival of patients treated with these regimens
Compare the time to distant recurrence in patients treated with these regimens
Compare the incidence of new primary contralateral breast cancer in patients treated with these regimens
Compare the incidence of all clinical fractures specifically hip and vertebral fractures in patients treated with these regimens
Compare cardiovascular morbidity and mortality ie significant coronary heart disease which includes myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft fatal and nonfatal strokes and all vascular deaths in patients treated with these regimens
Correlate therapy induced changes in breast density with plasma hormones and growth factors drug levels of exemestane and anastrozole genetic variation and breast cancer recurrence or contralateral events in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to lymph node status at diagnosis negative vs positive vs unknown prior adjuvant chemotherapy yes vs no and herceptin use yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral exemestane 25 mg once daily for 5 years
Arm II Patients receive oral anastrozole 1 mg once daily for 5 years In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months during the first year of study participation and annually thereafter
PROJECTED ACCRUAL A total of 6840 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000316325 | OTHER | PDQ | None |
| CAN-NCIC-MA27 | OTHER | None | None |
| NCCTG-MA27 | OTHER | None | None |
| CALGB-CAN-NCIC-MA27 | OTHER | None | None |
| ECOG-CAN-NCIC-MA27 | OTHER | None | None |
| SWOG-CAN-NCIC-MA27 | OTHER | None | None |
| IBCSG-30-04 | OTHER | None | None |
| 2005-001893-28 | EUDRACT_NUMBER | None | None |