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

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ClinicalTrials.gov Identifier: NCT00343616
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Cognitive/Functional Effects Fatigue Psychosocial Effects of Cancer and Its Treatment Procedure: cognitive assessment Procedure: fatigue assessment and management Procedure: psychologic distress Procedure: quality-of-life assessment Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
Study Start Date : April 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2009

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Objective cognitive function as measured by the CogState battery [ Time Frame: 6 years after randomization ]

Secondary Outcome Measures :
  1. Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ) [ Time Frame: 6 years after randomization ]
  2. Psychological distress as measured by the General Health Questionnaire (GHQ) [ Time Frame: 6 years after randomization ]
  3. Fatigue as measured by the Brief Fatigue Inventory (BFI) [ Time Frame: 6 years after randomization ]
  4. Quality of life as measured by the IBCSG QL Core Form [ Time Frame: 6 years after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343616


Locations
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Australia, New South Wales
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia, 3065
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Italy
European Institute of Oncology
Milan, Italy, 20141
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1
Switzerland
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
International Breast Cancer Study Group
Bern, Switzerland, CH-3008
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
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Study Chair: Kelly-Anne Phillips Peter MacCallum Cancer Centre, Australia
Study Chair: Juerg Bernhard, PhD International Breast Cancer Study Group
More Information
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Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00343616    
Other Study ID Numbers: CDR0000482396
IBCSG-18-98-CFS
IBCSG-1-98-CFS
NOVARTIS-2026703019
EU-20624
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012
Keywords provided by International Breast Cancer Study Group:
cognitive/functional effects
fatigue
psychosocial effects of cancer and its treatment
 stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases