Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

NCT05964504 | Recruiting

• 1 other identifier: 237513
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Metastatic Breast Cancer; Lobular Breast Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Proportion of participants who are currently taking estrogen receptor modulators or degraders

  Up to 10 years

• Mean Change in Circulating tumor DNA (ctDNA)

  Up to 10 years

• Number of novel imaging tools

  Up to 10 years

• Number of new tumor markers introduced

  Up to 10 years

• Number of participants enrolled in clinical trials

  Up to 10 years

Study Arms (1)

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

Interventions

Blood Specimen PROCEDURE

Blood will be drawn via venipuncture

Initial Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants with histologically proven stage IV invasive lobular carcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• METAvivor Research and Support, Inc: collaborator
• University of California, San Francisco: lead

Study Sites (4)

University of California, San Diego

San Diego, California, 92053, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94122, United States

RECRUITING

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained from participants

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Lobular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rita Mukhtar, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Quirarte

CONTACT

415-476-8390; Astrid.Quirarte@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): February 28, 2036
• Study Completion (Estimated): February 28, 2036
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)