Clinical trial · Interventional
Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98
Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
NCT00343616CI-TRIAL-00007569completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| fatigue assessment and management | Procedure | — | UNRESOLVED |
| psychologic distress | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Tamoxifen for 5 years
- description
- Patients treated with tamoxifen for 5 years after randomization.
- interventionNames
- Procedure: cognitive assessment
- Procedure: fatigue assessment and management
- Procedure: psychologic distress
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Letrozole for 5 years
- description
- Patients treated with letrozole for 5 years after randomization.
- interventionNames
- Procedure: cognitive assessment
- Procedure: fatigue assessment and management
- Procedure: psychologic distress
- Procedure: quality-of-life assessment
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.