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Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
This study is ongoing, but not recruiting participants.
Sponsored by: International Breast Cancer Study Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00343616
  Purpose

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 Intervention Phase
Breast Cancer
Cancer-Related Problem/Condition
Fatigue
Procedure: cognitive assessment
Procedure: fatigue assessment and management
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective cognitive function as measured by the CogState battery

Secondary Outcome Measures:
  • Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
  • Psychological distress as measured by the General Health Questionnaire (GHQ)
  • Fatigue as measured by the Brief Fatigue Inventory (BFI)
  • Quality of life as measured by the IBCSG QL Core Form

Estimated Enrollment: 148
Study Start Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343616

Locations
Australia, New South Wales
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Victoria
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia, 3065
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
International Breast Cancer Study Group
Bern, Switzerland, CH-3008
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
United Kingdom, Scotland
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
Study Chair: Kelly-Anne Phillips Peter MacCallum Cancer Centre, Australia
Investigator: Jurg Bernhard, PhD International Breast Cancer Study Group
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000482396, IBCSG-18-98-CFS, IBCSG-1-98-CFS, NOVARTIS-2026703019, EU-20624
Study First Received: June 22, 2006
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00343616  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
cognitive/functional effects
fatigue
psychosocial effects/treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:
Signs and Symptoms
Fatigue
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009