Know Cancer

forgot password

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

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

Thank you

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 HospitalBethesda, Maryland  20814
Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
Chester County HospitalWest Chester, Pennsylvania  19380
Batte Cancer Center at Northeast Medical CenterConcord, North Carolina  28025
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Elkhart General HospitalElkhart, Indiana  46515
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Salinas Valley Memorial HospitalSalinas, California  93901
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Upper Michigan Cancer Center at Marquette General HospitalMarquette, Michigan  49855
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
St. Charles Mercy HospitalOregon, Ohio  43616
St. Mary Regional Cancer CenterLanghorne, Pennsylvania  19047
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Carl and Dorothy Bennett Cancer Center at Stamford HospitalStamford, Connecticut  06904
Harbin Clinic Cancer Center - Medical OncologyRome, Georgia  30165
McFarland Clinic, PCAmes, Iowa  50010
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311
Community HospitalMunster, Indiana  46321
Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California  91204
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Providence Cancer CenterAnchorage, Alaska  99508
Cancer Center at Phoenixville HospitalPhoenixville, Pennsylvania  19460
Center for Cancer Care at OSF Saint Anthony Medical CenterRockford, Illinois  61108
Mercy General HospitalSacramento, California  95819
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
NSMC Cancer Center - PeabodyPeabody, Massachusetts  01960
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Bendheim Cancer Center at Greenwich HospitalGreenwich, Connecticut  06830
Norwalk HospitalNorwalk, Connecticut  06856
Community Regional Cancer Care at Community Hospital NorthIndianapolis, Indiana  46256
Community Regional Cancer Care at Community Hospital EastIndianapolis, Indiana  46219