Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Specimen.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer, Lobular Breast Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Procedure Blood Specimen
Blood will be drawn via venipuncture
Primary outcome measures
- Feasibility of registry [Time frame: Up to 2 years]
- Proportion of patients with measurable versus unmeasurable disease [Time frame: Up to 10 years]
- Median Progression Free Survival Rate [Time frame: Up to 10 years]
- Median Overall Survival Rates [Time frame: Up to 10 years]
Secondary outcome measures (5)
- Proportion of participants who are currently taking estrogen receptor modulators or degraders [Time frame: Up to 10 years]
- Mean Change in Circulating tumor DNA (ctDNA) [Time frame: Up to 10 years]
- Number of novel imaging tools [Time frame: Up to 10 years]
- Number of new tumor markers introduced [Time frame: Up to 10 years]
- Number of participants enrolled in clinical trials [Time frame: Up to 10 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- University of California, San Diego — San Diego
- University of California, San Francisco — San Francisco
- Abramson Cancer Center — Philadelphia
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT05964504 · 237513