Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Laura Huppert, MD (ucsf)Michelle Melisko, MD (ucsf)
Headshot of Laura Huppert
Laura Huppert
Headshot of Michelle Melisko
Michelle Melisko

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:
  2. The impact of whole brain radiation versus stereotactic radiosurgery on QOL.
  3. The impact of brain metastasis surgical resection on QOL.
  4. The impact of CNS-penetrant systemic therapies on QOL.
  5. The impact of craniospinal irradiation and other treatment modalities for LMD on QOL.

EXPLORATORY OBJECTIVES:

  1. 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.

Keywords

Breast Cancer, Quality of Life, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer, Leptomeningeal Metastasis of Breast Cancer, Brain Metastases From Breast Cancer, Quality of Life, Breast Neoplasms, Neoplasm Metastasis, Surveys and Questionnaires, Medical Chart Review

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientists at University of California Health

  • Laura Huppert, MD (ucsf)
    Dr. Laura Huppert is an oncologist who cares for patients with all stages of breast cancer. Huppert's research focuses on designing and conducting clinical trials to evaluate new cancer treatments, including ways to combine therapies so as to improve outcomes.
  • Michelle Melisko, MD (ucsf)
    Dr. Michelle E. Melisko is a cancer specialist with expertise in breast cancer treatment and research. She is interested in testing new chemotherapy combinations, biological therapies and immunotherapies for breast cancer, with a particular focus on treatment of cancer that has spread to the brain.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07659652
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated