Clinical trial NCT00659373: Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02
Official title: Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Fatigue
Sleep Disorders
Keywords: 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
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Breast Cancer Trials, Australia and New Zealand
name: Cancer and Leukemia Group B
First posted: 2008-04-16
Enrollment: 86
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Completely resected disease
* 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:

    * 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

PATIENT CHARACTERISTICS:

* Premenopausal
* Can speak and read the local language(s) fluently

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: 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)
timeFrame: 1 year after patient randomization to parent IBCSG 24-02 study
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Fort Collins
country: United States
facility: Front Range Cancer Specialists
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital Cancer Center
state: Georgia
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: CCOP - Atlanta Regional
state: Georgia
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Concord
country: United States
facility: New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
state: New Hampshire
city: Manhasset
country: United States
facility: Don Monti Comprehensive Cancer Center at North Shore University Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospitals - Memorial Campus
state: North Carolina
city: Concord
country: United States
facility: Batte Cancer Center at Northeast Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre - General Campus
state: Ontario
Study officials:
affiliation: ETOP IBCSG Partners Foundation
name: Juerg Bernhard, PhD
role: STUDY_CHAIR
affiliation: Peter MacCallum Cancer Centre, Australia
name: Kelly-Anne Phillips
role: STUDY_CHAIR
affiliation: Cancer and Leukemia Group B
name: Timothy Ahles, MD
role: STUDY_CHAIR
References:
citation: 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.