Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964504
• Other study ID #: 237513
• Status: Recruiting
• Start date: December 20, 2024
• Est. completion date: February 28, 2034

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: Astrid Quirarte
• Phone: 415-476-8390
• Email: Astrid.Quirarte[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 28, 2034
• Est. primary completion date: February 28, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Lobular
• Lobular Breast Carcinoma
• Metastatic Breast Cancer

Intervention

Procedure:
• Blood Specimen
Blood will be drawn via venipuncture

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Up to 2 years
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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