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NCT Number: NCT07659652

Quality of Life for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location contact

Amy Langdon

CONTACT

[email protected]

877-827-3222

Laura Huppert, MD

PRINCIPAL_INVESTIGATOR

Michelle Melisko, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health-Related Quality of Life (QOL) questionnaires

Other

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

medical chart review

Other

Data will be collected from the participants electronic medical record

Other names: Medical Record Review

Primary outcomes

  1. Overall changes in reported symptom burden

    Time frame: Every 3 months for up to approximately 5 years.

    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

  2. Frequency of moderate to severe symptoms

    Time frame: Every 3 months for up to approximately 5 years

    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.

  3. Overall change in scores on reported symptom interference (MDASI-BT)

    Time frame: Every 3 months for up to approximately 5 years

    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

  4. 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.

    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.

  5. 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.

    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.

Secondary outcomes

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

    Time frame: Up to 5 years

    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.

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

    Time frame: Up to 5 years

    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.

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

    Time frame: Up to 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Langdon

CONTACT

[email protected]

877-827-3222

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2035
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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