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NCT05964504Recruiting

Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

University of California, San Francisco

Start Date

12/20/2023

Completion Date

2/28/2036

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

PROCEDURE

Blood Specimen

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Conditions

Metastatic Breast CancerLobular Breast Carcinoma

Locations

University of California, San Diego

San Diego, California 92053

United States

University of California, San Francisco

San Francisco, California 94122

United States

Abramson Cancer Center

Philadelphia, Pennsylvania 19104

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States