search
Back to results

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

Primary Purpose

Breast Cancer, Cognitive/Functional Effects, Fatigue

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cognitive assessment
fatigue assessment and management
psychologic distress
quality-of-life assessment
Sponsored by
ETOP IBCSG Partners Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring cognitive/functional effects, fatigue, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Oncology at Prince of Wales Hospital
  • Peter MacCallum Cancer Centre
  • St. Vincent's Hospital - Melbourne
  • Cabrini Hospital
  • Institut Jules Bordet
  • European Institute of Oncology
  • Auckland City Hospital
  • Universitaetsspital-Basel
  • Oncology Institute of Southern Switzerland
  • International Breast Cancer Study Group
  • Kantonsspital - St. Gallen
  • Ninewells Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tamoxifen for 5 years

Letrozole for 5 years

Tamoxifen 2 years plus letrozole 3 years

Letrozole for 2 years plus tamoxifen for 3 years

Arm Description

Patients treated with tamoxifen for 5 years after randomization.

Patients treated with letrozole for 5 years after randomization.

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

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

Outcomes

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

Full Information

First Posted
June 22, 2006
Last Updated
July 26, 2012
Sponsor
ETOP IBCSG Partners Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00343616
Brief Title
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
Official Title
Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETOP IBCSG Partners Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cognitive/Functional Effects, Fatigue, Psychosocial Effects of Cancer and Its Treatment
Keywords
cognitive/functional effects, fatigue, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen for 5 years
Arm Type
Experimental
Arm Description
Patients treated with tamoxifen for 5 years after randomization.
Arm Title
Letrozole for 5 years
Arm Type
Experimental
Arm Description
Patients treated with letrozole for 5 years after randomization.
Arm Title
Tamoxifen 2 years plus letrozole 3 years
Arm Type
Experimental
Arm Description
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
Arm Title
Letrozole for 2 years plus tamoxifen for 3 years
Arm Type
Experimental
Arm Description
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Description
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
Intervention Type
Procedure
Intervention Name(s)
fatigue assessment and management
Intervention Description
Fatigue will be evaluated using the Brief Fatigue Inventory.
Intervention Type
Procedure
Intervention Name(s)
psychologic distress
Intervention Description
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective cognitive function as measured by the CogState battery
Time Frame
6 years after randomization
Secondary Outcome Measure Information:
Title
Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
Time Frame
6 years after randomization
Title
Psychological distress as measured by the General Health Questionnaire (GHQ)
Time Frame
6 years after randomization
Title
Fatigue as measured by the Brief Fatigue Inventory (BFI)
Time Frame
6 years after randomization
Title
Quality of life as measured by the IBCSG QL Core Form
Time Frame
6 years after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly-Anne Phillips
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juerg Bernhard, PhD
Organizational Affiliation
ETOP IBCSG Partners Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Oncology at Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
St. Vincent's Hospital - Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
International Breast Cancer Study Group
City
Bern
ZIP/Postal Code
CH-3008
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs