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Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers

Phase 3
Open (Enrolling)
Breast Cancer, Fatigue, Sleep Disorders

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Trial Information

Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers



- To evaluate and compare changes in cognitive function over 1 year in premenopausal
breast cancer patients who receive adjuvant tamoxifen with or without ovarian function
suppression (OFS).


- To compare the effect of tamoxifen with OFS versus exemestane with OFS on cognitive
function over 1 year.

- To compare the effect of tamoxifen alone versus exemestane with OFS on cognitive
function over 1 year.

- To evaluate and compare changes in cognitive function over 5 years and 6 years between
the 3 treatment groups (pending funding becoming available for the year 5 and 6
measures) on clinical trial IBCSG-2402.

- To explore the impact of receiving or not receiving prior chemotherapy on changes in
cognitive function.

- To explore the relationship between subjective and objective cognitive function.

- To explore the relationship between cognitive function, psychological distress,
fatigue, insomnia, and quality of life.

OUTLINE: This is a multicenter study.

Patients undergo objective cognitive function assessment over 20-25 minutes, using the
CogState computerized test battery, which consists of five tasks that measure the speed of
psychomotor function, visual attention, working memory and the accuracy of working memory,
learning and memory and executive function (all non-verbal). They undergo subjective
cognitive function assessment, using the Cognitive Failures Questionnaire (CFQ), a 25-item
self-report measure that assesses a person's failures in memory, perception, and motor
function over the past 6 months. Patients also complete General Health Questionnaire -12
(measuring psychologic distress), Brief Fatigue Inventory, NCI Common Terminology Criteria
for Adverse Events, and a patient-rated linear analogue self-assessment (LASA) scale
measuring insomnia. Patients complete these assessments at baseline (after registration to
clinical trial IBCSG-2402, but before beginning protocol therapy) and at 1, 5, and 6 years
after randomization on IBCSG-2402.

Relevant clinical factors, such as age, adjuvant chemotherapy, co-morbidity and concomitant
medications are assessed. In addition, language, education, psychiatric and neurological
history, alcohol consumption and right/left handedness are also assessed.

Inclusion Criteria


- Histologically confirmed breast cancer

- Completely resected disease

- Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal

- Has not yet received any of the following adjuvant endocrine therapy, either
before or after registration on IBCSG-2402:

- Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist

- Ovarian irradiation

- Bilateral oophorectomy

- Hormone receptor status:

- Estrogen and/or progesterone receptor positive

- Each tumor must be hormone receptor positive


- Premenopausal

- Can speak and read the local language(s) fluently


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in cognitive function over 1 year in premenopausal breast cancer patients who receive adjuvant tamoxifen with or without ovarian function suppression (OFS)

Outcome Time Frame:

1 year after patient randomization

Safety Issue:


Principal Investigator

Juerg Bernhard, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

International Breast Cancer Study Group


United States: Federal Government

Study ID:




Start Date:

December 2007

Completion Date:

June 2016

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Sleep Disorders
  • cognitive/functional effects
  • psychosocial effects of cancer and its treatment
  • fatigue
  • sleep disorders
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Fatigue
  • Sleep Disorders
  • Parasomnias



Suburban Hospital Bethesda, Maryland  20814
Roswell Park Cancer Institute Buffalo, New York  14263
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington, West Virginia  25701
Chester County Hospital West Chester, Pennsylvania  19380
Batte Cancer Center at Northeast Medical Center Concord, North Carolina  28025
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Elkhart General Hospital Elkhart, Indiana  46515
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Front Range Cancer Specialists Fort Collins, Colorado  80528
Salinas Valley Memorial Hospital Salinas, California  93901
John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek, California  94598
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Upper Michigan Cancer Center at Marquette General Hospital Marquette, Michigan  49855
Kingsbury Center for Cancer Care at Cheshire Medical Center Keene, New Hampshire  03431
St. Charles Mercy Hospital Oregon, Ohio  43616
St. Mary Regional Cancer Center Langhorne, Pennsylvania  19047
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut  06360
Carl and Dorothy Bennett Cancer Center at Stamford Hospital Stamford, Connecticut  06904
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
McFarland Clinic, PC Ames, Iowa  50010
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay, Wisconsin  54311
Community Hospital Munster, Indiana  46321
Glendale Memorial Hospital Comprehensive Cancer Center Glendale, California  91204
MBCCOP - Meharry Medical College - Nashville Nashville, Tennessee  37208-3599
Providence Cancer Center Anchorage, Alaska  99508
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
Center for Cancer Care at OSF Saint Anthony Medical Center Rockford, Illinois  61108
Mercy General Hospital Sacramento, California  95819
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
NSMC Cancer Center - Peabody Peabody, Massachusetts  01960
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Bendheim Cancer Center at Greenwich Hospital Greenwich, Connecticut  06830
Norwalk Hospital Norwalk, Connecticut  06856
Community Regional Cancer Care at Community Hospital North Indianapolis, Indiana  46256
Community Regional Cancer Care at Community Hospital East Indianapolis, Indiana  46219