NCT05964504 · University of California, San Francisco
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
What this study is about
This is a forward-looking observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.
View original scientific description
This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.
Interventions
PROCEDURE
Blood Specimen
Blood will be drawn via venipuncture
Primary outcome measures
Feasibility of registry
Time frame: Up to 2 years
Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in \>=75% of treating medical oncologists
Proportion of patients with measurable versus unmeasurable disease
Time frame: Up to 10 years
Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist.
Median Progression Free Survival Rate
Time frame: Up to 10 years
The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Median Overall Survival Rates
Time frame: Up to 10 years
The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is allowed.
- Age \>=18 years
- Any receptor subtype.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
- Stage I-III breast cancer.
- Lack of lobular histology on tumor biopsy.
- Other active cancer (prior treated cancer with no current evidence of disease is allowed).
Where
- San Diego, California
- San Francisco, California
- Philadelphia, Pennsylvania
- Houston, Texas
Collaborators
METAvivor Research and Support, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations