Clinical trial NCT00343616: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
First posted: 2006-06-23
Enrollment: 135
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective cognitive function as measured by the CogState battery
timeFrame: 6 years after randomization
Secondary outcomes:
measure: Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
timeFrame: 6 years after randomization
measure: Psychological distress as measured by the General Health Questionnaire (GHQ)
timeFrame: 6 years after randomization
measure: Fatigue as measured by the Brief Fatigue Inventory (BFI)
timeFrame: 6 years after randomization
measure: Quality of life as measured by the IBCSG QL Core Form
timeFrame: 6 years after randomization
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Institute of Oncology at Prince of Wales Hospital
state: New South Wales
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital - Melbourne
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Milan
country: Italy
facility: European Institute of Oncology
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
city: Bern
country: Switzerland
facility: International Breast Cancer Study Group
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Kelly-Anne Phillips
role: STUDY_CHAIR
affiliation: ETOP IBCSG Partners Foundation
name: Juerg Bernhard, PhD
role: STUDY_CHAIR
References: