Metastatic Breast Cancer, Lobular Breast Carcinoma
Conditions
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.
Interventions
PROCEDUREBlood Specimen
Blood will be drawn via venipuncture
Sponsors
University of California, San Francisco
METAvivor Research and Support, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of registry | Up to 2 years | 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 |
| Proportion of patients with measurable versus unmeasurable disease | Up to 10 years | 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. |
| Median Progression Free Survival Rate | Up to 10 years | The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool. |
| Median Overall Survival Rates | Up to 10 years | The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who are currently taking estrogen receptor modulators or degraders | Up to 10 years | 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. |
| Mean Change in Circulating tumor DNA (ctDNA) | Up to 10 years | 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. |
| Number of novel imaging tools | Up to 10 years | 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. |
| Number of new tumor markers introduced | Up to 10 years | 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. |
| Number of participants enrolled in clinical trials | Up to 10 years | 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. |
Countries
United States
Contacts
CONTACTAstrid Quirarte
PRINCIPAL_INVESTIGATORRita Mukhtar, MD
University of California, San Francisco
Outcome results
None listed