Eligible patients: Patients with histologically confirmed metastatic (stage IV) lobular breast cancer, regardless of receptor type or line of therapy, are eligible. Patients must also be over the age of 18. The study will enroll approximately 40 patients in 6 institutions across the United States.
Description of Trial/Summary: The multi-center PLUMB Study’s goal is to develop better ways of monitoring disease and objective endpoints to increase enrollment in trials. To do this, we will test whether a blood-based liquid biopsy approach can provide an accurate biomarker for monitoring disease status. We will then evaluate changes in liquid biopsy to see if they correlate with the clinical assessment of disease status. This type of serial monitoring will result in a biomarker that can be used for treatment decisions, earlier intervention, and as a surrogate endpoint in clinical trials.
Background: Patients with metastatic lobular breast cancer are less likely to enroll in clinical trials and suffer from a lack of subtype specific research and data. One of the major problems facing patients with metastatic lobular breast cancer is that imaging tests do not detect metastatic lobular tumors as well as other tumor types. Most metastatic breast cancer trials require that a patient has “measurable” disease so that an objective assessment can be made regarding whether treatment is effective.
Why is this study beneficial?/Important?
The findings from this study have the potential to change treatment for those with metastatic lobular breast cancer and improve outcomes by testing if a blood-based liquid biopsy approach can provide an accurate biomarker for monitoring disease status.
Principal Investigator:
Dr. Rita Mukhtar, MD, Associate Professor of Clinical Surgery, University of California-San Francisco (UCSF)
Trial Contact:
Astrid Quirarte, Research Coordinator: ilcresearch@ucsf.edu
Trial Location(s):
The PLUMB Study is currently open to patients being seen at the University of California- San Francisco. PLUMB also plans to open locations at MD Anderson-Houston, University of California-San Diego, The Cleveland Clinic -Cleveland Ohio, The University of Pennsylvania, and University of Utah.
Time Commitment: At every standard of care imaging scan, (approximately every 3-6 months or as determined by your medical oncologist) participants will have their blood drawn and their medical oncologist’s disease assessment will be collected.
More Information:
ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05964504?term=PLUMB&rank=1
UCSF Clinical Trials Website: https://clinicaltrials.ucsf.edu/trial/NCT05964504
