Breast CancerPhase 3NCT00343616
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
A Phase 3 study testing cognitive assessment, fatigue assessment and management and psychologic distress in people with Breast Cancer and Cognitive/Functional Effects, run by ETOP IBCSG Partners Foundation at 12 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer, Cognitive/Functional Effects, Fatigue
- What is being tested?
- cognitive assessment, fatigue assessment and management and psychologic distress
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Apr 2005to May 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Australia4 sites
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, 3065
Cabrini Hospital
Malvern, Victoria, 3144
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, 2031
Switzerland4 sites
Universitaetsspital-Basel
Basel, CH-4031
Oncology Institute of Southern Switzerland
Bellinzona, CH-6500
International Breast Cancer Study Group
Bern, CH-3008
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Cognitive/Functional Effects, Fatigue, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- cognitive assessment, fatigue assessment and management, psychologic distress, quality-of-life assessment
- Keywords
- cognitive/functional effects, fatigue, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentProcedure or surgery
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
fatigue assessment and managementProcedure or surgery
Fatigue will be evaluated using the Brief Fatigue Inventory.
psychologic distressProcedure or surgery
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
quality-of-life assessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen for 5 years | Experimental | Patients treated with tamoxifen for 5 years after randomization. Receives: Procedure: cognitive assessment; Procedure: fatigue assessment and management; Procedure: psychologic distress; Procedure: quality-of-life assessment |
| Letrozole for 5 years | Experimental | Patients treated with letrozole for 5 years after randomization. Receives: Procedure: cognitive assessment; Procedure: fatigue assessment and management; Procedure: psychologic distress; Procedure: quality-of-life assessment |
| Tamoxifen 2 years plus letrozole 3 years | Experimental | Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. Receives: Procedure: cognitive assessment; Procedure: fatigue assessment and management; Procedure: psychologic distress; Procedure: quality-of-life assessment |
| Letrozole for 2 years plus tamoxifen for 3 years | Experimental | Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. Receives: Procedure: cognitive assessment; Procedure: fatigue assessment and management; Procedure: psychologic distress; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cognitive function as measured by the CogState battery
Measured: 6 years after randomization
Secondary outcomes (4)
Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
Measured: 6 years after randomization
Psychological distress as measured by the General Health Questionnaire (GHQ)
Measured: 6 years after randomization
Fatigue as measured by the Brief Fatigue Inventory (BFI)
Measured: 6 years after randomization
Quality of life as measured by the IBCSG QL Core Form
Measured: 6 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startApr 2005
- Primary completionMay 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kelly-Anne Phillips, Study chair, Peter MacCallum Cancer Centre, AustraliaJuerg Bernhard, PhD, Study chair, ETOP IBCSG Partners Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343616
- Sponsor's protocol ID
- CDR0000482396
- Other IDs
- IBCSG-18-98-CFS, IBCSG-1-98-CFS, NOVARTIS-2026703019, EU-20624
- Status last verified
- Jul 2012
- First submitted
- 22 Jun 2006
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
- ClinicalTrials.gov ID
- NCT00343616
- Acronym / sponsor ID
- CDR0000482396
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Study start
- Apr 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen for 5 years | Experimental | Procedure: cognitive assessment, Procedure: fatigue assessment and management, Procedure: psychologic distress, Procedure: quality-of-life assessmentPatients treated with tamoxifen for 5 years after randomization. |
| Letrozole for 5 years | Experimental | Procedure: cognitive assessment, Procedure: fatigue assessment and management, Procedure: psychologic distress, Procedure: quality-of-life assessmentPatients treated with letrozole for 5 years after randomization. |
| Tamoxifen 2 years plus letrozole 3 years | Experimental | Procedure: cognitive assessment, Procedure: fatigue assessment and management, Procedure: psychologic distress, Procedure: quality-of-life assessmentPatients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. |
| Letrozole for 2 years plus tamoxifen for 3 years | Experimental | Procedure: cognitive assessment, Procedure: fatigue assessment and management, Procedure: psychologic distress, Procedure: quality-of-life assessmentPatients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive assessmentCognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire. | Procedure or surgery | Letrozole for 2 years plus tamoxifen for 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
| fatigue assessment and managementFatigue will be evaluated using the Brief Fatigue Inventory. | Procedure or surgery | Letrozole for 2 years plus tamoxifen for 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
| psychologic distressPsychologic distress will be evaluated using the General Health Questionnaire after cognitive testing. | Procedure or surgery | Letrozole for 2 years plus tamoxifen for 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
| quality-of-life assessmentQuality 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. | Procedure or surgery | Letrozole for 2 years plus tamoxifen for 3 years, Letrozole for 5 years, Tamoxifen 2 years plus letrozole 3 years, Tamoxifen for 5 years |
Primary outcome
Objective cognitive function as measured by the CogState battery
Time frame: 6 years after randomization
4 secondary outcomes
Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)
Time frame: 6 years after randomization
Psychological distress as measured by the General Health Questionnaire (GHQ)
Time frame: 6 years after randomization
Fatigue as measured by the Brief Fatigue Inventory (BFI)
Time frame: 6 years after randomization
Quality of life as measured by the IBCSG QL Core Form
Time frame: 6 years after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly-Anne Phillips study chair
Peter MacCallum Cancer Centre, Australia
Juerg Bernhard, PhD study chair
ETOP IBCSG Partners Foundation
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cognitive assessment, fatigue assessment and management and psychologic distress in people with Breast Cancer and Cognitive/Functional Effects, run by ETOP IBCSG Partners Foundation at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, Switzerland, Belgium, Italy, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cognitive function as measured by the CogState battery (time frame: 6 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.