Clinical trial NCT05964504: Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Breast Cancer
Lobular Breast Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with histologically proven stage IV invasive lobular carcinoma

Brief 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: 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).

Primary outcomes:
measure: Feasibility of registry
timeFrame: Up to 2 years
measure: Proportion of patients with measurable versus unmeasurable disease
timeFrame: Up to 10 years
measure: Median Progression Free Survival Rate
timeFrame: Up to 10 years
measure: Median Overall Survival Rates
timeFrame: Up to 10 years
Secondary outcomes:
measure: Proportion of participants who are currently taking estrogen receptor modulators or degraders
timeFrame: Up to 10 years
measure: Mean Change in Circulating tumor DNA (ctDNA)
timeFrame: Up to 10 years
measure: Number of novel imaging tools
timeFrame: Up to 10 years
measure: Number of new tumor markers introduced
timeFrame: Up to 10 years
measure: Number of participants enrolled in clinical trials
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Rita Mukhtar, MD
role: PRINCIPAL_INVESTIGATOR
References: