Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
NCT ID: NCT05964504
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
12 participants
OBSERVATIONAL
2023-12-20
2034-02-28
Brief Summary
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Detailed Description
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1. To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer.
2. To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data.
Secondary Aims:
1. To evaluate the correlation between imaging findings and disease progression.
2. To evaluate the correlation between ctDNA and disease progression.
3. To develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.
Outline:
Participants will be recruited to participate in the registry during a regularly scheduled clinic visit with their treating oncologist, and consented to participate at this time. At each evaluation time point, participants will have a blood draw performed. Participants will be followed until loss to follow up, death, or withdrawal from the registry.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Initial Cohort
Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes, for plasma isolation, cell free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within +/- 14 days of whole body imaging studies which will occur when patients are scheduled for standard of care whole body imaging.
Blood Specimen
Blood will be drawn via venipuncture
Interventions
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Blood Specimen
Blood will be drawn via venipuncture
Eligibility Criteria
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Inclusion Criteria
2. Age \>=18 years
3. Any receptor subtype.
4. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
2. Lack of lobular histology on tumor biopsy.
3. Other active cancer (prior treated cancer with no current evidence of disease is allowed).
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Rita Mukhtar, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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237513
Identifier Type: -
Identifier Source: org_study_id
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