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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Metastases From Breast Cancer; Breast Cancer, Metastatic; Breast Cancer, Metastatic Breast Cancer; Breast Cancer, Quality of Life; Leptomeningeal Metastasis of Breast Cancer
• Intervention / Treatment: Other: Health-Related Quality of Life (QOL) questionnaires; Other: Medical Chart Review

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Amy Langdon; Phone Number: 877-827-3222; Email: Amy.DeLuca@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Contact: Email: cancertrials@ucsf.edu
      • Principal Investigator: Laura Huppert, MD
      • Principal Investigator: Michelle Melisko, MD
      • Contact: Amy Langdon; Phone Number: 877-827-3222; Email: Amy.DeLuca@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants at University of California, San Francisco who are actively receiving care for cancer that has spread to the brain and/or leptomeninges.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with Metastatic Breast Cancer; 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).

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 Names: Health-Related Quality of Life (HrQOL) questionnaires; Symptom Questionnaire; Other: Medical Chart Review; Data will be collected from the participants electronic medical record; Other Names: Medical Record Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall changes in reported symptom burden	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	Every 3 months for up to approximately 5 years.
Frequency of moderate to severe symptoms	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. The frequency of responses to the MDASI-BT items with a score of 4 or higher will be reported as a percentage of the total number of participants.	Every 3 months for up to approximately 5 years
Overall change in scores on reported symptom interference (MDASI-BT)	Participants will complete the 6-item section of the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the interference of cancer symptoms during the last 24 hours. Participants responses are given on a scale from 0 (no interference) to 10 (interfered complete) and address general activity, mood, work/housework, relationships, walking, and enjoyment of life. The higher the score the more the symptom interfered with daily life. 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	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	This 8-item questionnaire to measure cognitive function based on responses to statements about how the participants feel regarding various cognitive tasks in the past 7 days with responses ranging from 5="Never" to 1="Very Often", and a total raw score ranging from 8 - 40, which are converted to a scaled T-score (range 22.41 to 63.48) with lower scores indicating a greater impairment of cognitive function.	Up to 5 years.
Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function Questionnaire over time	This 6-item questionnaire to measures self-reported capability to physically function in the context of cancer and/or cancer treatment experiences, based on responses to statements about how the participants feel regarding various physical tasks in the past 7 days with responses ranging from 5="Without difficulty" to 1="Unable to do", or 5="Not at all" to 1="Cannot do" and a total raw score ranging from 6 - 30, which are converted to a scaled T-score with a range from 20.8 -59), with lower scores indicating a greater impairment of physical function.	Every 3 months for approximately 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen	The overall changes in scores on the PROMIS cognitive function scores by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models.	Up to 5 years
Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen	The overall changes in scores on both the PROMIS physical function scores by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models.	Up to 5 years
Changes in MDASI-BT scores over time by non-investigational treatment regimen	The overall changes in scores on the MDASI-BT by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models.	Up to 5 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Laura Huppert, MD, University of California, San Francisco; Principal Investigator: Michelle Melisko, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Neoplasm Metastasis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements; Surveys and Questionnaires; Quality of Life
• Other Study ID Numbers: 26757; NCI-2026-04200 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No