Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
NCT ID: NCT00343616
Last Updated: 2012-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2005-04-30
2009-05-31
Brief Summary
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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
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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) (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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomization.
cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
quality-of-life assessment
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.
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomization.
cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
quality-of-life assessment
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.
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
quality-of-life assessment
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.
Letrozole for 2 years plus tamoxifen for 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
quality-of-life assessment
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.
Interventions
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cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
quality-of-life assessment
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.
Eligibility Criteria
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Inclusion Criteria
* Estrogen receptor- and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent hormone replacement therapy
30 Years
FEMALE
No
Sponsors
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ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Kelly-Anne Phillips
Role: STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Juerg Bernhard, PhD
Role: STUDY_CHAIR
ETOP IBCSG Partners Foundation
Locations
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Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Institut Jules Bordet
Brussels, , Belgium
European Institute of Oncology
Milan, , Italy
Auckland City Hospital
Auckland, , New Zealand
Universitaetsspital-Basel
Basel, , Switzerland
Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
International Breast Cancer Study Group
Bern, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Ninewells Hospital
Dundee, Scotland, United Kingdom
Countries
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Other Identifiers
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IBCSG-18-98-CFS
Identifier Type: -
Identifier Source: secondary_id
IBCSG-1-98-CFS
Identifier Type: -
Identifier Source: secondary_id
NOVARTIS-2026703019
Identifier Type: -
Identifier Source: secondary_id
EU-20624
Identifier Type: -
Identifier Source: secondary_id
CDR0000482396
Identifier Type: -
Identifier Source: org_study_id