Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Adult participants with histologically proven stage IV invasive lobular carcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood Specimen
Procedure/SurgeryBlood will be drawn via venipuncture
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Initial Cohort1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of registry
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
Time frame
Up to 2 years2
Proportion of patients with measurable versus unmeasurable disease
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.
Time frame
Up to 10 years3
Median Progression Free Survival Rate
The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Time frame
Up to 10 years4
Median Overall Survival Rates
The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Time frame
Up to 10 yearsSecondary outcomes
1
Proportion of participants who are currently taking estrogen receptor modulators or degraders
The overall proportion of participants who are currently taking estrogen receptor modulators or degraders which may interfere with a radiolabeled form of estradiol (FES) in a positron Emission Tomography (PET) versus the participants medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.
Time frame
Up to 10 years2
Mean Change in Circulating tumor DNA (ctDNA)
The overall change in quantity of ctDNA mean tumor molecules per mL blood versus medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.
Time frame
Up to 10 years3
Number of novel imaging tools
The number of novel imaging tools developed during the course of data collection to improve the determination of disease status will be utilized to develop the ILC specific response assessment tool.
Time frame
Up to 10 years4
Number of new tumor markers introduced
The number of participants who have detectable mutations on ctDNA evaluations with are correlated with health outcomes will be utilized to develop the ILC specific response assessment tool.
Time frame
Up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
METAvivor Research and Support, Inc
Collaborator
Source ClinicalTrials.gov