Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Cognitive/Functional Effects Fatigue Psychosocial Effects of Cancer and Its Treatment

Keywords

cognitive/functional effectsfatiguepsychosocial effects of cancer and its treatmentstage I breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

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

Study Arms (4)

Tamoxifen for 5 years

EXPERIMENTAL

Patients treated with tamoxifen for 5 years after randomization.

Procedure: cognitive assessmentProcedure: fatigue assessment and managementProcedure: psychologic distressProcedure: quality-of-life assessment

Letrozole for 5 years

EXPERIMENTAL

Patients treated with letrozole for 5 years after randomization.

Procedure: cognitive assessmentProcedure: fatigue assessment and managementProcedure: psychologic distress

Interventions

cognitive assessmentProcedure

Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.

Letrozole for 2 years plus tamoxifen for 3 yearsLetrozole for 5 yearsTamoxifen 2 years plus letrozole 3 yearsTamoxifen for 5 years

fatigue assessment and managementProcedure

Eligibility Criteria

Age30 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Enrolled in protocol IBCSG-1-98 * Must be in the fifth year of study treatment (i.e., still receiving tamoxifen or letrozole) * 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 * Estrogen receptor- and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent hormone replacement therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

ETOP IBCSG Partners Foundation
Research networklead

Study Sites (12)

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Peter MacCallum Cancer Centre

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

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

Mental Status and Dementia TestsTherapeutics

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests

Study Officials

Kelly-Anne Phillips
Peter MacCallum Cancer Centre, Australia
STUDY CHAIR
Juerg Bernhard, PhD
ETOP IBCSG Partners Foundation
STUDY CHAIR

Enrollment

135 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 22, 2006

First Posted

June 23, 2006

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Tamoxifen for 5 years

Letrozole for 5 years

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Tamoxifen 2 years plus letrozole 3 years

Letrozole for 2 years plus tamoxifen for 3 years

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Tamoxifen for 5 years

Letrozole for 5 years

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Tamoxifen 2 years plus letrozole 3 years

Letrozole for 2 years plus tamoxifen for 3 years

Source record

Locations