Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer; Lobular Breast Carcinoma
• Intervention / Treatment: Procedure: Blood Specimen

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.

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Astrid Quirarte; Phone Number: 415-476-8390; Email: Astrid.Quirarte@ucsf.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92053
      • Recruiting
      • University of California, San Diego
      • Principal Investigator: Rebecca Shatsky, MD
    • San Francisco, California, United States, 94122
      • Recruiting
      • University of California, San Francisco
      • Principal Investigator: Rita Mukhtar, MD
      • Contact: Astrid Quirarte; Phone Number: 415-476-8390; Email: Astrid.Quirarte@ucsf.edu
      • Principal Investigator: A. Jo Chien, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center
      • Principal Investigator: Rachel Jankowitz, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: Jason Mouabbi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult participants with histologically proven stage IV invasive lobular carcinoma

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: Blood Specimen; Blood will be drawn via venipuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 2 years
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.	Up to 10 years
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.	Up to 10 years
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.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 10 years
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.	Up to 10 years
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.	Up to 10 years
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.	Up to 10 years
Number of participants enrolled in clinical trials	The number of participants with metastatic ILC who have enrolled on a clinical trial will be utilized to develop the ILC specific response assessment tool.	Up to 10 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: METAvivor Research and Support, Inc
• Investigators: Principal Investigator: Rita Mukhtar, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): February 28, 2036
• Study Completion (Estimated): February 28, 2036

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Skin and Connective Tissue Diseases; Breast Neoplasms; Carcinoma, Lobular; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 237513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No