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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00343616
First received: June 22, 2006
Last updated: July 26, 2012
Last verified: July 2012

June 22, 2006
July 26, 2012
April 2005
May 2008   (final data collection date for primary outcome measure)
Objective cognitive function as measured by the CogState battery [ Time Frame: 6 years after randomization ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00343616 on ClinicalTrials.gov Archive Site
  • Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ) [ Time Frame: 6 years after randomization ] [ Designated as safety issue: No ]
  • Psychological distress as measured by the General Health Questionnaire (GHQ) [ Time Frame: 6 years after randomization ] [ Designated as safety issue: No ]
  • Fatigue as measured by the Brief Fatigue Inventory (BFI) [ Time Frame: 6 years after randomization ] [ Designated as safety issue: No ]
  • Quality of life as measured by the IBCSG QL Core Form [ Time Frame: 6 years after randomization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Cognitive/Functional Effects
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment
  • 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 for 5 years
    Patients treated with tamoxifen for 5 years after randomization.
    Interventions:
    • Procedure: cognitive assessment
    • Procedure: fatigue assessment and management
    • Procedure: psychologic distress
    • Procedure: quality-of-life assessment
  • Experimental: Letrozole for 5 years
    Patients treated with letrozole for 5 years after randomization.
    Interventions:
    • Procedure: cognitive assessment
    • Procedure: fatigue assessment and management
    • Procedure: psychologic distress
    • Procedure: quality-of-life assessment
  • Experimental: Tamoxifen 2 years plus letrozole 3 years
    Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
    Interventions:
    • Procedure: cognitive assessment
    • Procedure: fatigue assessment and management
    • Procedure: psychologic distress
    • Procedure: quality-of-life assessment
  • Experimental: Letrozole for 2 years plus tamoxifen for 3 years
    Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
    Interventions:
    • Procedure: cognitive assessment
    • Procedure: fatigue assessment and management
    • Procedure: psychologic distress
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
May 2009
May 2008   (final data collection date for primary outcome measure)

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
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Italy,   New Zealand,   Switzerland,   United Kingdom
 
NCT00343616
CDR0000482396, IBCSG-18-98-CFS, IBCSG-1-98-CFS, NOVARTIS-2026703019, EU-20624
Yes
International Breast Cancer Study Group
International Breast Cancer Study Group
Not Provided
Study Chair: Kelly-Anne Phillips Peter MacCallum Cancer Centre, Australia
Study Chair: Juerg Bernhard, PhD International Breast Cancer Study Group
International Breast Cancer Study Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP