Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98

Phase 3

Completed

• Conditions: Cognitive/Functional Effects; Psychosocial Effects of Cancer and Its Treatment; Breast Cancer; Fatigue
• Interventions: Procedure: cognitive assessment; Procedure: fatigue assessment and management; Procedure: psychologic distress; Procedure: quality-of-life assessment

• Registration Number: NCT00343616
• Lead Sponsor: ETOP IBCSG Partners Foundation

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.

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) (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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-23
• Primary Completion: 2008-05
• Study Completion: 2009-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole for 2 years plus tamoxifen for 3 years	cognitive assessment	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Letrozole for 2 years plus tamoxifen for 3 years	quality-of-life assessment	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Tamoxifen for 5 years	fatigue assessment and management	Patients treated with tamoxifen for 5 years after randomization.
Tamoxifen for 5 years	psychologic distress	Patients treated with tamoxifen for 5 years after randomization.
Letrozole for 2 years plus tamoxifen for 3 years	psychologic distress	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Tamoxifen for 5 years	cognitive assessment	Patients treated with tamoxifen for 5 years after randomization.
Tamoxifen for 5 years	quality-of-life assessment	Patients treated with tamoxifen for 5 years after randomization.
Letrozole for 5 years	cognitive assessment	Patients treated with letrozole for 5 years after randomization.
Letrozole for 5 years	psychologic distress	Patients treated with letrozole for 5 years after randomization.
Tamoxifen 2 years plus letrozole 3 years	cognitive assessment	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Tamoxifen 2 years plus letrozole 3 years	fatigue assessment and management	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Tamoxifen 2 years plus letrozole 3 years	psychologic distress	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Tamoxifen 2 years plus letrozole 3 years	quality-of-life assessment	Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Letrozole for 2 years plus tamoxifen for 3 years	fatigue assessment and management	Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Letrozole for 5 years	fatigue assessment and management	Patients treated with letrozole for 5 years after randomization.
Letrozole for 5 years	quality-of-life assessment	Patients treated with letrozole for 5 years after randomization.

Primary Outcome Measures

Name	Time	Method
Objective cognitive function as measured by the CogState battery	6 years after randomization

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (12)

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

Institute of Oncology at Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Cabrini Hospital; 🇦🇺 Malvern, Victoria, Australia

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

International Breast Cancer Study Group; 🇨🇭 Bern, Switzerland

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Ninewells Hospital; 🇬🇧 Dundee, Scotland, United Kingdom

European Institute of Oncology; 🇮🇹 Milan, Italy

St. Vincent's Hospital - Melbourne; 🇦🇺 Fitzroy, Victoria, Australia