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Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02 (Co-SOFT)

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Australia and New Zealand Breast Cancer Trials Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00659373
First received: April 15, 2008
Last updated: July 11, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Fatigue
Sleep Disorders
Drug: Tamoxifen
Drug: triptorelin
Drug: Exemestane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Investigating Cognitive Function for Patients Participating in the SOFT Trial in Selected Centers

Resource links provided by NLM:


Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • 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) [ Time Frame: 1 year after patient randomization to parent IBCSG 24-02 study ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: December 2007
Study Completion Date: April 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Drug: Tamoxifen
Other Name: Nolvadex
Experimental: T+OFS
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)
Drug: Tamoxifen
Other Name: Nolvadex
Drug: triptorelin
Other Names:
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Experimental: E+OFS
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)
Drug: triptorelin
Other Names:
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Drug: Exemestane
Other Name: Aromasin

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

Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659373

Locations
United States, California
Mercy General Hospital
Sacramento, California, United States, 95819
United States, Colorado
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
United States, New York
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
International Breast Cancer Study Group
National Cancer Institute (NCI)
Australia and New Zealand Breast Cancer Trials Group
Cancer and Leukemia Group B
Investigators
Study Chair: Juerg Bernhard, PhD International Breast Cancer Study Group
Study Chair: Kelly-Anne Phillips Peter MacCallum Cancer Centre, Australia
Study Chair: Timothy Ahles, MD Cancer and Leukemia Group B
  More Information

Publications:
Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00659373     History of Changes
Other Study ID Numbers: CDR0000594003  IBCSG-24-02-ANZ0701  ANZ0701  CALGB-IBCSG-24-02-ANZ0701 
Study First Received: April 15, 2008
Results First Received: July 14, 2015
Last Updated: July 11, 2016
Health Authority: United States: Federal Government
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by International Breast Cancer Study Group:
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

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Sleep Wake Disorders
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Tamoxifen
Exemestane
Triptorelin Pamoate
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 27, 2016