Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98

ETOP IBCSG Partners Foundation

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment; Fatigue; Cognitive/Functional Effects

Treatments: Procedure: psychologic distress; Procedure: quality-of-life assessment; Procedure: fatigue assessment and management; Procedure: cognitive assessment

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00343616

CDR0000482396

IBCSG-18-98-CFS

NOVARTIS-2026703019

IBCSG-1-98-CFS

EU-20624

Details and patient eligibility

About

RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer.

PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.

Full description

OBJECTIVES:

Primary

• Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98.

Secondary

• Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years, having previously received an alternate hormonal therapy for 2 years.
• Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy.
• Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy.
• Assess the relationship between objective and subjective measures of cognitive function, including specific cognitive domains.
• Assess the relationship between cognitive function and psychological distress, fatigue, and quality of life.

OUTLINE: This is a longitudinal, multicenter study.

Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability, quality of life, fatigue, and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year* (post randomization on protocol IBCSG-1-98) (i.e., after completion of adjuvant hormonal therapy).

NOTE: *Patients who receive extended letrozole, hormone replacement therapy, or other endocrine therapy beyond 5 years do not undergo the 6-year assessment.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Enrollment: 135 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Enrolled in protocol IBCSG-1-98

  • Must be in the fifth year of study treatment (i.e., still receiving tamoxifen or letrozole)

• No breast cancer recurrence or second malignancy

• Patients who received 2-4½ years of tamoxifen and have chosen to switch to letrozole to complete 5 years of treatment on protocol IBCSG-1-98 are not eligible

• Hormone receptor status

  • Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

• Female
• Postmenopausal

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent hormone replacement therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 4 patient groups

Tamoxifen for 5 years

Experimental group

Description:

Patients treated with tamoxifen for 5 years after randomization.

Treatment:

Procedure: psychologic distress

Procedure: quality-of-life assessment

Procedure: fatigue assessment and management

Procedure: cognitive assessment

Letrozole for 5 years

Experimental group

Description:

Patients treated with letrozole for 5 years after randomization.

Treatment:

Procedure: psychologic distress

Procedure: quality-of-life assessment

Procedure: fatigue assessment and management

Procedure: cognitive assessment

Tamoxifen 2 years plus letrozole 3 years

Experimental group

Description:

Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.

Treatment:

Procedure: psychologic distress

Procedure: quality-of-life assessment

Procedure: fatigue assessment and management

Procedure: cognitive assessment

Letrozole for 2 years plus tamoxifen for 3 years

Experimental group

Description:

Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.

Treatment:

Procedure: psychologic distress

Procedure: quality-of-life assessment

Procedure: fatigue assessment and management

Procedure: cognitive assessment