Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343616
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2006-06-22
Brief Title:
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
Status:
COMPLETED
Status Verified Date:
2012-07
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 Studying cognitive function such as thinking attention concentration and memory in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer
PURPOSE This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98
PURPOSE This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98
Detailed Description:
OBJECTIVES
Primary
Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98
Secondary
Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years having previously received an alternate hormonal therapy for 2 years
Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy
Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy
Assess the relationship between objective and subjective measures of cognitive function including specific cognitive domains
Assess the relationship between cognitive function and psychological distress fatigue and quality of life
OUTLINE This is a longitudinal multicenter study
Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability quality of life fatigue and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year post randomization on protocol IBCSG-1-98 ie after completion of adjuvant hormonal therapy
NOTE Patients who receive extended letrozole hormone replacement therapy or other endocrine therapy beyond 5 years do not undergo the 6-year assessment
PROJECTED ACCRUAL A total of 148 patients will be accrued for this study
Primary
Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98
Secondary
Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years having previously received an alternate hormonal therapy for 2 years
Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy
Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy
Assess the relationship between objective and subjective measures of cognitive function including specific cognitive domains
Assess the relationship between cognitive function and psychological distress fatigue and quality of life
OUTLINE This is a longitudinal multicenter study
Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability quality of life fatigue and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year post randomization on protocol IBCSG-1-98 ie after completion of adjuvant hormonal therapy
NOTE Patients who receive extended letrozole hormone replacement therapy or other endocrine therapy beyond 5 years do not undergo the 6-year assessment
PROJECTED ACCRUAL A total of 148 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20624 | None | None | None |
| IBCSG-18-98-CFS | None | None | None |
| IBCSG-1-98-CFS | None | None | None |
| NOVARTIS-2026703019 | None | None | None |