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

July 26, 2012 updated by: ETOP IBCSG Partners Foundation

Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Institute of Oncology at Prince of Wales Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital - Melbourne
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
  • Italy
      • Milan, Italy, 20141
        • European Institute of Oncology
  • New Zealand
      • Auckland, New Zealand, 1
        • Auckland City Hospital
  • Switzerland
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bellinzona, Switzerland, CH-6500
        • Oncology Institute of Southern Switzerland
      • Bern, Switzerland, CH-3008
        • International Breast Cancer Study Group
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
  • United Kingdom
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomization.
Procedure: cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
Procedure: 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.
Experimental: Letrozole for 5 years
Patients treated with letrozole for 5 years after randomization.
Procedure: cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
Procedure: 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.
Experimental: Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Procedure: cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
Procedure: 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.
Experimental: Letrozole for 2 years plus tamoxifen for 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Procedure: cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
Procedure: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
Procedure: psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective cognitive function as measured by the CogState battery
Time Frame: 6 years after randomization
6 years after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
Time Frame: 6 years after randomization
6 years after randomization
Psychological distress as measured by the General Health Questionnaire (GHQ)
Time Frame: 6 years after randomization
6 years after randomization
Fatigue as measured by the Brief Fatigue Inventory (BFI)
Time Frame: 6 years after randomization
6 years after randomization
Quality of life as measured by the IBCSG QL Core Form
Time Frame: 6 years after randomization
6 years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETOP IBCSG Partners Foundation

Investigators

  • Study Chair: Kelly-Anne Phillips, Peter MacCallum Cancer Centre, Australia
  • Study Chair: Juerg Bernhard, PhD, ETOP IBCSG Partners Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

June 22, 2006

First Submitted That Met QC Criteria

June 22, 2006

First Posted (Estimate)

June 23, 2006

Study Record Updates

Last Update Posted (Estimate)

July 27, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000482396
  • NOVARTIS-2026703019 (Other Identifier: Novartis)
  • IBCSG-18-98-CFS
  • IBCSG-1-98-CFS
  • EU-20624

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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