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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Breast Cancer Study Group
• Collaborators: Australia and New Zealand Breast Cancer Trials Group; Breast Cancer Trials, Australia and New Zealand; Cancer and Leukemia Group B; National Cancer Institute (NCI)
• Treatments: Exemestane; Tamoxifen; Triptorelin Pamoate

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