Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090974
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2004-09-07
Brief Title:
Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I Stage II or Stage IIIA Primary Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Quality Of Life Companion Study For JMA27 NCIC-MA27 A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients
PURPOSE This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I stage II or stage IIIA primary breast cancer
PURPOSE This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I stage II or stage IIIA primary breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms FACT-ES questionnaire in postmenopausal women with receptor-positive stage I II or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27
Secondary
Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens
Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens
OUTLINE This is a multicenter companion study Patients receive treatment on CAN-NCIC-MA27
Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms FACT-ES questionnaire at baseline and at 3 6 12 and 24 months
PROJECTED ACCRUAL A total of 1253 patients will be accrued for this study
Primary
Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms FACT-ES questionnaire in postmenopausal women with receptor-positive stage I II or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27
Secondary
Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens
Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens
OUTLINE This is a multicenter companion study Patients receive treatment on CAN-NCIC-MA27
Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms FACT-ES questionnaire at baseline and at 3 6 12 and 24 months
PROJECTED ACCRUAL A total of 1253 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 |
|---|---|---|---|
| CAN-NCIC-E1Z03 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |
| ECOG-E1Z03 | None | None | None |