Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072462
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2003-11-04
Brief Title:
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
International Breast Cancer Intervention Study II IBIS-II DCIS
Status:
COMPLETED
Status Verified Date:
2024-04
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:
IBIS-II DCIS
Brief Summary:
RATIONALE Estrogen can stimulate the growth of breast cancer cells Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ
PURPOSE This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ
PURPOSE This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of adjuvant tamoxifen vs anastrozole in terms of local control and prevention of contralateral disease in postmenopausal women with locally excised ductal carcinoma in situ
Compare side effect profiles of these drugs in these patients
Secondary
Compare the efficacy of these drugs according to the receptor status of the primary or recurrent cancer in these patients
Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients
Compare breast cancer mortality in patients treated with these drugs
Compare the effect of these drugs on other cancers cardiovascular disease fracture rates and non-breast cancer deaths in these patients
Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs
OUTLINE This is a randomized double-blind multicentre study Patients are stratified according to participating centre Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tamoxifen and oral placebo once daily
Arm II Patients receive oral anastrozole and oral placebo once daily In both arms treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity
Patients are followed annually for 5 years and a further 5 years minimum off treatment
Peer Reviewed and Funded by Cancer Research UK Sponsored by Queen Mary University of London
ACTUAL ACCRUAL A total of 2980 patients were accrued for this study over 9 years
Primary
Compare the efficacy of adjuvant tamoxifen vs anastrozole in terms of local control and prevention of contralateral disease in postmenopausal women with locally excised ductal carcinoma in situ
Compare side effect profiles of these drugs in these patients
Secondary
Compare the efficacy of these drugs according to the receptor status of the primary or recurrent cancer in these patients
Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients
Compare breast cancer mortality in patients treated with these drugs
Compare the effect of these drugs on other cancers cardiovascular disease fracture rates and non-breast cancer deaths in these patients
Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs
OUTLINE This is a randomized double-blind multicentre study Patients are stratified according to participating centre Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tamoxifen and oral placebo once daily
Arm II Patients receive oral anastrozole and oral placebo once daily In both arms treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity
Patients are followed annually for 5 years and a further 5 years minimum off treatment
Peer Reviewed and Funded by Cancer Research UK Sponsored by Queen Mary University of London
ACTUAL ACCRUAL A total of 2980 patients were accrued for this study over 9 years
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 |
|---|---|---|---|
| ISRCTN31488319 | None | None | None |
| EU-20226 | None | None | None |
| BIG-5-02 | None | None | None |
| IBCSG-31-03-DCIS | None | None | None |