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

NCT07659652 | Not Yet Recruiting

• 2 other identifiers: 26757NCI-2026-04200
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer, Quality of Life; Breast Cancer, Metastatic; Breast Cancer, Metastatic Breast Cancer; Leptomeningeal Metastasis of Breast Cancer; Brain Metastases From Breast Cancer

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen

  Up to 5 years

• Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen

  Up to 5 years

• Changes in MDASI-BT scores over time by non-investigational treatment regimen

  Up to 5 years

Study Arms (1)

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; Other: Medical Chart Review

Interventions

Health-Related Quality of Life (QOL) questionnaires OTHER

Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic

Also known as: Health-Related Quality of Life (HrQOL) questionnaires, Symptom Questionnaire

Participants with Metastatic Breast Cancer

Medical Chart Review OTHER

Data will be collected from the participants electronic medical record

Also known as: Medical Record Review

Participants with Metastatic Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Laura Huppert, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Michelle Melisko, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Langdon

CONTACT

877-827-3222; Amy.DeLuca@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)