Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078832
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2004-03-08
Brief Title:
Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
International Breast Cancer Intervention Study
Status:
COMPLETED
Status Verified Date:
2018-04
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
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer Anastrozole may be effective in preventing breast cancer
PURPOSE This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease
PURPOSE This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease
Detailed Description:
OBJECTIVES
Primary
Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease
Secondary
Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants
Determine the effect of this drug on breast cancer mortality in these participants
Determine the effect of this drug on other cancers cardiovascular disease fracture rates and non-breast cancer deaths in these participants
Determine the tolerability and acceptability of side effects of this drug in these participants
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Participants are stratified according to participating center Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral anastrozole daily for 5 years
Arm II Participants receive an oral placebo daily for 5 years In both arms treatment continues in the absence of the development of breast cancer including ductal carcinoma in situ a drop in the T-score below minus 4 or the occurrence of a new fragility fracture
Participants are followed for at least a further 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
ACCRUAL A total of 3864 participants were recruited for this study over 10 years
Primary
Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease
Secondary
Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants
Determine the effect of this drug on breast cancer mortality in these participants
Determine the effect of this drug on other cancers cardiovascular disease fracture rates and non-breast cancer deaths in these participants
Determine the tolerability and acceptability of side effects of this drug in these participants
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Participants are stratified according to participating center Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral anastrozole daily for 5 years
Arm II Participants receive an oral placebo daily for 5 years In both arms treatment continues in the absence of the development of breast cancer including ductal carcinoma in situ a drop in the T-score below minus 4 or the occurrence of a new fragility fracture
Participants are followed for at least a further 5 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
ACCRUAL A total of 3864 participants were recruited for this study over 10 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 |
|---|---|---|---|
| EUDRACT-2004-003991-12 | None | None | None |
| EU-20227 | None | None | None |