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Trial Title:
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
NCT ID:
NCT05964504
Condition:
Metastatic Breast Cancer
Lobular Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Carcinoma, Lobular
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Blood Specimen
Description:
Blood will be drawn via venipuncture
Arm group label:
Initial Cohort
Summary:
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.
Detailed description:
Primary Aims:
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.
Criteria for eligibility:
Study pop:
Adult participants with histologically proven stage IV invasive lobular carcinoma
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Histologically confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is
allowed.
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:
1. Stage I-III breast cancer.
2. Lack of lobular histology on tumor biopsy.
3. Other active cancer (prior treated cancer with no current evidence of disease is
allowed).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Astrid Quirarte
Phone:
415-476-8390
Email:
Astrid.Quirarte@ucsf.edu
Investigator:
Last name:
Rita Mukhtar, MD
Email:
Principal Investigator
Investigator:
Last name:
A. Jo Chien, MD
Email:
Principal Investigator
Start date:
December 20, 2024
Completion date:
February 28, 2034
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05964504
