Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Lobular Breast Carcinoma; Metastatic Breast Cancer

Treatments: Procedure: Blood Specimen

Study type: Observational

Funder types: Other

Identifiers

NCT05964504

237513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

12 participants in 1 patient group

Initial Cohort

Description:

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.

Treatment:

Procedure: Blood Specimen