Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

Study Overview
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Brief Summary
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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
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Primary Aims: To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer. To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data. Secondary Aims: To evaluate the correlation between imaging findings and disease progression. To evaluate the correlation between ctDNA and disease progression. 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.

Official Title
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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

Conditions
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Metastatic Breast Cancer, Lobular Breast Carcinoma

Intervention / Treatment
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* Procedure: Blood Specimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Initial Cohort<br>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<br>* Blood will be drawn via venipuncture<br>|

What is the study measuring?
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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 |