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Not yet recruiting NCT07659652

Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease

— Observational Breast Cancer, Quality of Life Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Cancer Leptomeningeal Metastasis of Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health-Related Quality of Life (QOL) questionnaires, Medical Chart Review.
Who it may be relevant to
Registry conditions: Breast Cancer, Quality of Life, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer, Leptomeningeal Metastasis of Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To describe overall symptom experience and quality of life (QOL) over time in breast cancer patients with brain metastases and/or leptomeningeal disease.

SECONDARY OBJECTIVES:

I. To evaluate the impact of cancer-directed treatments over time on quality of life, physical function, and cognitive function in patients with breast cancer brain metastases and/or leptomeningeal disease including:

* The impact of whole brain radiation versus stereotactic radiosurgery on QOL. * The impact of brain metastasis surgical resection on QOL. * The impact of CNS-penetrant systemic therapies on QOL. * The impact of craniospinal irradiation and other treatment modalities for LMD on QOL.

EXPLORATORY OBJECTIVES:

I. To evaluate the interaction between QOL and demographics, social determinants of health, and control of systemic disease in patients with breast cancer brain metastases and/or leptomeningeal disease.

OUTLINE:

Participants will be given questionnaires and followed for at least 3 years but may withdraw at any time.

Interventions

  • Other Health-Related Quality of Life (QOL) questionnaires
    Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
  • Other Medical Chart Review
    Data will be collected from the participants electronic medical record

Primary outcome measures

  • Overall changes in reported symptom burden [Time frame: Every 3 months for up to approximately 5 years.]
  • Frequency of moderate to severe symptoms [Time frame: Every 3 months for up to approximately 5 years]
  • Overall change in scores on reported symptom interference (MDASI-BT) [Time frame: Every 3 months for up to approximately 5 years]
  • Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Cognitive Function Short Form 8a Questionnaire over time [Time frame: Up to 5 years.]
  • Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function Questionnaire over time [Time frame: Every 3 months for approximately 5 years.]
Secondary outcome measures (3)
  • Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen [Time frame: Up to 5 years]
  • Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen [Time frame: Up to 5 years]
  • Changes in MDASI-BT scores over time by non-investigational treatment regimen [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • Be male or female 18 years of age or older.
  • Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and/or leptomeninges.
  • Have the intention to start or continue anticancer therapy.
  • Be able to provide informed consent.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07659652 · 26757 · NCI-2026-04200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗