Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002644
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-17
First Post:
1999-11-01
Brief Title:
Tamoxifen for the Prevention of Breast Cancer in High-Risk Women
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
International Breast Cancer Intervention Study A Multicentre Trial of Tamoxifen to Prevent Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2019-02
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-1
Brief Summary:
The International Breast Cancer Intervention Study I IBIS-I was designed to investigate the use of tamoxifen in preventing breast cancer in women with a higher risk of developing the disease Recruitment of women to IBIS-I ended in March 2001 and it recruited 7154 women from 36 centres in 9 countries The results of the study showed that tamoxifen reduced the incidence of breast cancer by one third in these high risk women but with some serious side effects IBIS-II was designed to continue the work started in IBIS-I by examining the role of anastrozole in the prevention of breast cancer which we hope will reduce breast cancer by even more than tamoxifen with less serious side effects
Detailed Description:
Established in 1992 the IBIS-I Study investigated the efficacy of tamoxifen a hormonal drug used to prevent breast cancer versus a placebo drug taken daily for five years in terms of reduction of breast cancer incidence in pre and postmenopausal women at high risk of developing breast cancer It was a double-blind randomised placebo-controlled trial that recruited 7154 women internationally of which 4277 were UK participants aged 35-70 years The primary outcome measure was the incidence of breast cancer including ductal carcinoma in situ cancer cells in the lining of the breast milk duct and side effects present in the patients were also investigated
Recruitment to the study completed in 2001 and the intervention placebotamoxifen ended in 2007 In early 2008 the Research Ethics Committee REC approved the conversion of IBIS-I to an epidemiological cohort study During 2007-2016 participants were followed-up via an annual postal questionnaire
In 2002 initial results found that tamoxifen reduced the risk of invasive breast cancer by 31 Mortality from non-breast cancer causes was not increased by tamoxifen However the analysis concluded that the overall riskbenefit ratio for the use of tamoxifen in prevention remained unclear and that continued follow-up of trial participants was essential A 2007 analysis on long-term tamoxifen prophylaxis for breast cancer confirmed the preventive effect of tamoxifen in terms of breast cancer incidence and that this was constant for the entire follow-up period No reduction in size of benefit was observed for up to ten years following participant randomisation Additionally tamoxifen-related side effects such as thrombo-embolism were not increased anymore after the 5-year treatment period These results therefore demonstrate that the benefit-to-risk ratio of tamoxifen improves with increasing duration of follow-up Thus how much additional benefit will be seen long-term remains an important question
Recruitment to the study completed in 2001 and the intervention placebotamoxifen ended in 2007 In early 2008 the Research Ethics Committee REC approved the conversion of IBIS-I to an epidemiological cohort study During 2007-2016 participants were followed-up via an annual postal questionnaire
In 2002 initial results found that tamoxifen reduced the risk of invasive breast cancer by 31 Mortality from non-breast cancer causes was not increased by tamoxifen However the analysis concluded that the overall riskbenefit ratio for the use of tamoxifen in prevention remained unclear and that continued follow-up of trial participants was essential A 2007 analysis on long-term tamoxifen prophylaxis for breast cancer confirmed the preventive effect of tamoxifen in terms of breast cancer incidence and that this was constant for the entire follow-up period No reduction in size of benefit was observed for up to ten years following participant randomisation Additionally tamoxifen-related side effects such as thrombo-embolism were not increased anymore after the 5-year treatment period These results therefore demonstrate that the benefit-to-risk ratio of tamoxifen improves with increasing duration of follow-up Thus how much additional benefit will be seen long-term remains an important question
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN91879928 | REGISTRY | ISRCTN | None |
| 2005-003091-38 | EUDRACT_NUMBER | None | None |