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

NCT00659373 | Completed Phase 3 Results DMC

• 4 other identifiers: CDR0000594003IBCSG-24-02-ANZ0701ANZ0701CALGB-IBCSG-24-02-ANZ0701
• Study Type: interventional
• Target: 86
• Locations: 2 countries
• Sites: 15

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Tamoxifen

ACTIVE COMPARATOR

Tamoxifen 20mg orally daily for 5 years

Drug: Tamoxifen

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)

Drug: Tamoxifen; Drug: triptorelin

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)

Drug: triptorelin; Drug: Exemestane

Interventions

Tamoxifen DRUG

Also known as: Nolvadex

T+OFS; Tamoxifen

triptorelin DRUG

Also known as: GnRH analogue, Trelstar Depot, Decapeptyl Depot

E+OFS; T+OFS

Exemestane DRUG

Also known as: Aromasin

E+OFS

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation: lead
• National Cancer Institute (NCI): collaborator
• Breast Cancer Trials, Australia and New Zealand: collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (15)

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80528, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, 03301, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 27092785 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Sleep Wake Disorders

Interventions

Tamoxifen; Triptorelin Pamoate; Gonadotropin-Releasing Hormone; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Rudolph Maibach, Executive Officer for International Trial Activities
• Organization: IBCSG

rudolf.maibach@ibcsg.org

+41 31 389 91 96

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 16, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2016
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-07

Locations

CA (2); US (13)