Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083174
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2004-05-14
Brief Title:
Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing 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:
ExCel
Brief Summary:
RATIONALE The MAP3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen
PURPOSE The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane
PURPOSE The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane
Detailed Description:
OBJECTIVES
Primary
Previously To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo
Currently To determine the frequency of serious adverse events for post-menopausal women at high-risk of developing breast cancer who choose to receive 5 years of exemestane as preventative therapy
Secondary
Previously same as is currently listed in PDQ Currently To address the Trial Committee and Sponsors commitment to allow women who are randomized to the MAP3 trial to receive 5 years of exemestane therapy
OUTLINE This study was a randomized double-blind placebo-controlled multicentre study Protocol-specified analyses were performed in April 2011 The results of these analyses are posted in the Results section Following the amendment of May 2011 the study is now open-label and all eligible patients are receiving exemestane from participating sites for a total of 5 years After exemestane is stopped there is no further follow-up
PROJECTED ACCRUALThere were 4560 women from the United States Canada Spain and France who took part in this study
Primary
Previously To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo
Currently To determine the frequency of serious adverse events for post-menopausal women at high-risk of developing breast cancer who choose to receive 5 years of exemestane as preventative therapy
Secondary
Previously same as is currently listed in PDQ Currently To address the Trial Committee and Sponsors commitment to allow women who are randomized to the MAP3 trial to receive 5 years of exemestane therapy
OUTLINE This study was a randomized double-blind placebo-controlled multicentre study Protocol-specified analyses were performed in April 2011 The results of these analyses are posted in the Results section Following the amendment of May 2011 the study is now open-label and all eligible patients are receiving exemestane from participating sites for a total of 5 years After exemestane is stopped there is no further follow-up
PROJECTED ACCRUALThere were 4560 women from the United States Canada Spain and France who took part in 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 |
|---|---|---|---|
| CDR0000363802 | OTHER | PDQ | None |
| CAN-NCIC-MAP3 | REGISTRY | None | None |
| PFIZER-EXEAPO-0028-150 | OTHER | None | None |