Clinical trial · Observational
Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
NCT07659652CI-TRIAL-00123504not yet recruitingClinicalTrials.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)
Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC). The goal of this research is to understand symptom burden and quality of life trajectories in this population and how treatments guide care management decisions.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases From Breast Cancer | — | UNRESOLVED | — |
| Breast Cancer, Metastatic | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer, Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Breast Cancer, Quality of Life | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Leptomeningeal Metastasis of Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health-Related Quality of Life (QOL) questionnaires | Other | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Metastatic Breast Cancer
- description
- This is a prospective cohort study of patients with Stage 4 (metastatic) breast cancer with brain metastases and/or leptomeningeal disease who are receiving treatment for cancer or cancer-related disease. Through a series of surveys, participants will be asked about race/menopausal status, social determinants, symptom experience, and cognitive and physical functioning. Participants will be asked to update surveys every 3 months. Additional demographic and on-investigational / routine care treatment information will be obtained from the Electronic Medical Record (EMR).
- interventionNames
- Other: Health-Related Quality of Life (QOL) questionnaires
- Other: Medical Chart Review
Primary outcomes (5)
- measure
- Overall changes in reported symptom burden
- timeFrame
- Every 3 months for up to approximately 5 years.
- description
- Participants will complete the 22-item MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the severity of various symptoms related to cancer (13 items) and symptoms specifically related to brain cancer (9 items) during the last 24 hours. Participants responses are given on a scale from 0 (not present) to 10 (worst possible). The higher the score the more severe the symptom. A subset of the most prevalent or severe symptoms reported will be used to represent symptom burden. Additional information on the questionnaire development scoring and copyright details can be found at https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/md-anderson-symptom-inventory-brain-tumor.html
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be male or female 18 years of age or older. 2. Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and/or leptomeninges. 3. Have the intention to start or continue anticancer therapy. 4. Be able to provide informed consent. 5. Be able to speak and read English. Exclusion Criteria: Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.
References
Publications (0)
Data not yet available
No reference posted for this study.