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| ID | Type | Description | Link |
|---|---|---|---|
| IBCSG-24-02-ANZ0701 | |||
| ANZ0701 | |||
| CALGB-IBCSG-24-02-ANZ0701 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Breast Cancer Trials, Australia and New Zealand | OTHER |
| Cancer and Leukemia Group B | NETWORK |
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RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression (E+ OFS) on brain function may help doctors plan cancer treatment.
PURPOSE: This study is looking at brain function in premenopausal women who are receiving adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical trial IBCSG-2402.
OBJECTIVES:
Primary:
* To evaluate and compare the changes in cognitive function over one year in premenopausal breast cancer patients who receive adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS).
OUTLINE: This is a multicenter study.
Objective cognitive function was measured with the CogState computerized test battery. The CogState battery consists of seven tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT), and ISLT-Delayed Recall. Performance speed is measured for the Detection, Identification and Monitoring tasks and performance accuracy is measured for the Memory, Learning, ISLT, and ISLT-Delayed Recall. Measures of performance speed are normalized using measures of performance accuracy (%) are normalized using arcsine transformation. The main outcome measure is a composite score which is the average of these task scores (after transformation and standardization by age-specific norms). Patients complete these assessments at baseline (i.e. before start of protocol hormonal therapy) and approximately one year after randomization to the parent IBCSG 24-02 (SOFT) study.
Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Active Comparator | Tamoxifen 20mg orally daily for 5 years |
|
| T+OFS | Experimental | Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) |
|
| E+OFS | Experimental | Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug |
|
| |
| triptorelin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS) | Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study. | 1 year after patient randomization to parent IBCSG 24-02 study |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy
Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:
Hormone receptor status:
Estrogen and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Juerg Bernhard, PhD | ETOP IBCSG Partners Foundation | Study Chair |
| Kelly-Anne Phillips | Peter MacCallum Cancer Centre, Australia | Study Chair |
| Timothy Ahles, MD | Cancer and Leukemia Group B | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy General Hospital | Sacramento | California | 95819 | United States | ||
| Front Range Cancer Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27092785 | Result | Phillips KA, Regan MM, Ribi K, Francis PA, Puglisi F, Bellet M, Spazzapan S, Karlsson P, Budman DR, Zaman K, Abdi EA, Domchek SM, Feng Y, Price KN, Coates AS, Gelber RD, Maruff P, Boyle F, Forbes JF, Ahles T, Fleming GF, Bernhard J. Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer. 2016 Apr 26;114(9):956-64. doi: 10.1038/bjc.2016.71. Epub 2016 Apr 19. |
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Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen | Tamoxifen 20mg orally daily for 5 years |
| FG001 | Ovarian Function Suppression | Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Exemestane | Drug |
|
|
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Northside Hospital Cancer Center | Atlanta | Georgia | 30342-1611 | United States |
| Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342-1701 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Batte Cancer Center at Northeast Medical Center | Concord | North Carolina | 28025 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 1C4 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen | Tamoxifen 20mg orally daily for 5 years |
| BG001 | Ovarian Function Suppression | Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation). Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS) | Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study. | Posted | Mean | Standard Deviation | standardized units | 1 year after patient randomization to parent IBCSG 24-02 study |
|
|
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamoxifen | Tamoxifen 20mg orally daily for 5 years | 0 | 20 | 0 | 20 | ||
| EG001 | Ovarian Function Suppression | Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) | 0 | 54 | 0 | 54 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rudolph Maibach, Executive Officer for International Trial Activities | IBCSG | +41 31 389 91 96 | rudolf.maibach@ibcsg.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D017329 | Triptorelin Pamoate |
| D007987 | Gonadotropin-Releasing Hormone |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Male |
|