Breast Cancer, Quality of LifeNCT07659652
Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
An observational study of Breast Cancer, Quality of Life and Breast Cancer, Metastatic, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Quality of Life, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Health-Related Quality of Life (QOL) questionnaires and Medical Chart Review
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Amy Langdon, 877-827-3222, Amy.DeLuca@ucsf.edu
cancertrials@ucsf.edu
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Breast Cancer, Quality of Life, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer, Leptomeningeal Metastasis of Breast Cancer, Brain Metastases From Breast Cancer
- Being tested
- Health-Related Quality of Life (QOL) questionnaires, Medical Chart Review
- Keywords
- Quality of Life
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-Related Quality of Life (QOL) questionnairesOther
Also called Health-Related Quality of Life (HrQOL) questionnaires, Symptom Questionnaire
Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
Medical Chart ReviewOther
Also called Medical Record Review
Data will be collected from the participants electronic medical record
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Health-Related Quality of Life (QOL) questionnaires; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Every 3 months for approximately 5 years.
Secondary outcomes (3)
Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen
The overall changes in scores on the Patient-Reported Outcomes Measurement Information System (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.
Measured: 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.
Measured: Up to 5 years
Changes in MDASI-BT scores over time by non-investigational treatment regimen
The overall changes in scores on the MD Anderson Symptom Inventory for Brain Tumor (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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Huppert, MD, Principal investigator, University of California, San FranciscoMichelle Melisko, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659652
- Sponsor's protocol ID
- 26757
- Other IDs
- NCI-2026-04200
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
- ClinicalTrials.gov ID
- NCT07659652
- Acronym / sponsor ID
- 26757
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Metastatic Breast Cancer | – | Other: Health-Related Quality of Life (QOL) questionnaires, Other: Medical Chart ReviewThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-Related Quality of Life (QOL) questionnairesAlso: Health-Related Quality of Life (HrQOL) questionnaires, Symptom QuestionnaireParticipants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic | Other | Participants with Metastatic Breast Cancer |
| Medical Chart ReviewAlso: Medical Record ReviewData will be collected from the participants electronic medical record | Other | Participants with Metastatic Breast Cancer |
Primary outcome
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
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.
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
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Huppert, MD principal investigator
University of California, San Francisco
Michelle Melisko, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, Quality of Life and Breast Cancer, Metastatic, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Langdon (877-827-3222, Amy.DeLuca@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall changes in reported symptom burden (time frame: Every 3 months for up to approximately 5 years.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.