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NCT05964504 | RECRUITING | Metastatic Breast Cancer


Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
Sponsor:

University of California, San Francisco

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.

Condition or disease

Metastatic Breast Cancer

Lobular Breast Carcinoma

Intervention/treatment

Blood Specimen

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 12 participants
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
Actual Study Start Date : 2023-12-20
Estimated Primary Completion Date : 2034-02-28
Estimated Study Completion Date : 2034-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).

Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

Location Details

NCT05964504


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


NOT YET RECRUITING

United States, California

University of California, San Diego

San Diego, California, United States, 92053

RECRUITING

United States, California

University of California, San Francisco

San Francisco, California, United States, 94122

NOT YET RECRUITING

United States, Pennsylvania

Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

NOT YET RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

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