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.
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.
Study Type
OBSERVATIONAL
Enrollment
12
Blood will be drawn via venipuncture
University of California, San Diego
San Diego, California, United States
NOT_YET_RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGAbramson Cancer Center
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGFeasibility 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 years
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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MD Anderson Cancer Center
Houston, Texas, United States
NOT_YET_RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 years