Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05964504

Conditions

Metastatic Breast Cancer

Lobular Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Specimen

Study Details

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.

Conditions

Metastatic Breast Cancer

Lobular Breast Carcinoma

Study ID

NCT05964504

Start date

Dec 20, 2023

Status verified date

Aug, 2026

Completion date

Feb 28, 2036

Anticipated

Primary completion date

Feb 28, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Initial Cohort

Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes, for plasma isolation, cell free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within +/- 14 days of whole body imaging studies which will occur when patients are scheduled for standard of care whole body imaging.

Interventions

Blood Specimen

Blood will be drawn via venipuncture

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Venezia Garza

415-353-8732venezia.garza@ucsf.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92053

Principal Investigator:

Rebecca Shatsky, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94122

Contacts

Venezia Garza

415-353-8732venezia.garza@ucsf.edu

Principal Investigator:

Rita Mukhtar, MD

Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Rachel Jankowitz, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Jason Mouabbi, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-02.