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)

ETOP IBCSG Partners Foundation

Status and phase: Completed; Phase 3

Conditions: Sleep Disorders; Breast Cancer; Fatigue

Treatments: Drug: triptorelin; Drug: Tamoxifen; Drug: Exemestane

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00659373

IBCSG-24-02-ANZ0701

ANZ0701

CALGB-IBCSG-24-02-ANZ0701

CDR0000594003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: Female

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

86 participants in 3 patient groups

Tamoxifen

Active Comparator group

Description:

Tamoxifen 20mg orally daily for 5 years

Treatment:

Drug: Tamoxifen

T+OFS

Experimental group

Description:

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)

Treatment:

Drug: Tamoxifen

Drug: triptorelin

E+OFS

Experimental group

Description:

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)

Treatment:

Drug: Exemestane

Drug: triptorelin