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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00343616




Registration number
NCT00343616
Ethics application status
Date submitted
22/06/2006
Date registered
23/06/2006
Date last updated
27/07/2012

Titles & IDs
Public title
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
Scientific title
Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
Secondary ID [1] 0 0
IBCSG-18-98-CFS
Secondary ID [2] 0 0
CDR0000482396
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Cognitive/Functional Effects 0 0
Fatigue 0 0
Psychosocial Effects of Cancer and Its Treatment 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - cognitive assessment
Treatment: Surgery - fatigue assessment and management
Treatment: Surgery - psychologic distress
Treatment: Surgery - quality-of-life assessment

Experimental: Tamoxifen for 5 years - Patients treated with tamoxifen for 5 years after randomization.

Experimental: Letrozole for 5 years - Patients treated with letrozole for 5 years after randomization.

Experimental: Tamoxifen 2 years plus letrozole 3 years - Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.

Experimental: Letrozole for 2 years plus tamoxifen for 3 years - Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.


Treatment: Surgery: cognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.

Treatment: Surgery: fatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.

Treatment: Surgery: psychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective cognitive function as measured by the CogState battery
Timepoint [1] 0 0
6 years after randomization
Secondary outcome [1] 0 0
Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
Timepoint [1] 0 0
6 years after randomization
Secondary outcome [2] 0 0
Psychological distress as measured by the General Health Questionnaire (GHQ)
Timepoint [2] 0 0
6 years after randomization
Secondary outcome [3] 0 0
Fatigue as measured by the Brief Fatigue Inventory (BFI)
Timepoint [3] 0 0
6 years after randomization
Secondary outcome [4] 0 0
Quality of life as measured by the IBCSG QL Core Form
Timepoint [4] 0 0
6 years after randomization

Eligibility
Key inclusion 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
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Institute of Oncology at Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Italy
State/province [2] 0 0
Milan
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Switzerland
State/province [4] 0 0
Basel
Country [5] 0 0
Switzerland
State/province [5] 0 0
Bellinzona
Country [6] 0 0
Switzerland
State/province [6] 0 0
Bern
Country [7] 0 0
Switzerland
State/province [7] 0 0
St. Gallen
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00343616
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kelly-Anne Phillips
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00343616