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RecruitingObservational

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

NCT ID: NCT05964504Sponsor: University of California, San FranciscoLast updated: 2026-03-17

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.

Arms & interventions

  • ProcedureBlood Specimen

    Blood will be drawn via venipuncture

Outcome measures

Primary

  • 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 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 10 years

Secondary

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

    Time frame: Up to 10 years

  • Mean Change in Circulating tumor DNA (ctDNA)

    Time frame: Up to 10 years

  • Number of novel imaging tools

    Time frame: Up to 10 years

  • Number of new tumor markers introduced

    Time frame: Up to 10 years

  • Number of participants enrolled in clinical trials

    Time frame: Up to 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (4)

University of California, San Diego

San Diego, California, 92053

Recruiting
Rebecca Shatsky, MD · Principal Investigator

University of California, San Francisco

San Francisco, California, 94122

Recruiting
Astrid Quirarte · Contact
415-476-8390Astrid.Quirarte@ucsf.edu
Rita Mukhtar, MD · Principal Investigator
A. Jo Chien, MD · Principal Investigator

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Recruiting
Rachel Jankowitz, MD · Principal Investigator

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Jason Mouabbi, MD · Principal Investigator