Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IBCSG-18-98-CFS | |||
| IBCSG-1-98-CFS | |||
| NOVARTIS-2026703019 | |||
| EU-20624 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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) (i.e., 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen for 5 years | Experimental | Patients treated with tamoxifen for 5 years after randomization. |
|
| Letrozole for 5 years | Experimental | Patients treated with letrozole for 5 years after randomization. |
|
| Tamoxifen 2 years plus letrozole 3 years | Experimental | Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. |
|
| Letrozole for 2 years plus tamoxifen for 3 years | Experimental | Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive assessment | Procedure | Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective cognitive function as measured by the CogState battery | 6 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ) | 6 years after randomization | |
| Psychological distress as measured by the General Health Questionnaire (GHQ) | 6 years after randomization |
Not provided
DISEASE CHARACTERISTICS:
Enrolled in protocol IBCSG-1-98
No breast cancer recurrence or second malignancy
Patients who received 2-4½ years of tamoxifen and have chosen to switch to letrozole to complete 5 years of treatment on protocol IBCSG-1-98 are not eligible
Hormone receptor status
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kelly-Anne Phillips | Peter MacCallum Cancer Centre, Australia | Study Chair |
| Juerg Bernhard, PhD | ETOP IBCSG Partners Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology at Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia | ||
| Peter MacCallum Cancer Centre |
Not provided
Not provided
Not provided
Not provided
Not provided
| fatigue assessment and management | Procedure | Fatigue will be evaluated using the Brief Fatigue Inventory. |
|
| psychologic distress | Procedure | Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing. |
|
| quality-of-life assessment | Procedure | Quality of life will be assessed using global linear analogue self-assessment (LASA) indicators for physical well-being, mood, coping effort (PACIS), perceived social support and subjective health estimation. |
|
| Fatigue as measured by the Brief Fatigue Inventory (BFI) | 6 years after randomization |
| Quality of life as measured by the IBCSG QL Core Form | 6 years after randomization |
| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| St. Vincent's Hospital - Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| European Institute of Oncology | Milan | 20141 | Italy |
| Auckland City Hospital | Auckland | 1 | New Zealand |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Oncology Institute of Southern Switzerland | Bellinzona | CH-6500 | Switzerland |
| International Breast Cancer Study Group | Bern | CH-3008 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Ninewells Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided