NCT00343616

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Apr 2005

Geographic Reach
6 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

June 22, 2006

Last Update Submit

July 26, 2012

Conditions

Breast CancerCognitive/Functional EffectsFatiguePsychosocial 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

  • 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

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 distressProcedure: quality-of-life assessment

Tamoxifen 2 years plus letrozole 3 years

EXPERIMENTAL

Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.

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

Letrozole for 2 years plus tamoxifen for 3 years

EXPERIMENTAL

Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.

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

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

Fatigue will be evaluated using the Brief Fatigue Inventory.

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

Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.

Letrozole for 2 years plus tamoxifen for 3 yearsLetrozole for 5 yearsTamoxifen 2 years plus letrozole 3 yearsTamoxifen for 5 years
quality-of-life assessmentPROCEDURE

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

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

Study Sites (12)

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

St. Vincent's Hospital - Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

International Breast Cancer Study Group

Bern, CH-3008, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

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 TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Kelly-Anne Phillips

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

  • Juerg Bernhard, PhD

    ETOP IBCSG Partners Foundation

    STUDY CHAIR

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 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2009

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

NZ(1)CH(4)IT(1)GB(1)AU(4)BE(1)