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NCT Number: NCT05964504

Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)

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.

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Key information

Conditions

Metastatic Breast Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Lobular Lobular Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego, San Diego, California, United States

Loading trial locations.

About this study

Primary Aims:

  • To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer.
  • To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data.

Secondary Aims:

  • To evaluate the correlation between imaging findings and disease progression.
  • To evaluate the correlation between ctDNA and disease progression.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood specimen

Procedure

Blood will be drawn via venipuncture

Primary outcomes

  1. Feasibility of registry

    Time frame: 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

  2. Proportion of patients with measurable versus unmeasurable disease

    Time frame: 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.

  3. Median Progression Free Survival Rate

    Time frame: 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.

  4. Median Overall Survival Rates

    Time frame: 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 outcomes

  1. Proportion of participants who are currently taking estrogen receptor modulators or degraders

    Time frame: 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.

  2. Mean Change in Circulating tumor DNA (ctDNA)

    Time frame: 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.

  3. Number of novel imaging tools

    Time frame: 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.

  4. Number of new tumor markers introduced

    Time frame: 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.

  5. Number of participants enrolled in clinical trials

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Venezia Garza

CONTACT

[email protected]

415-353-8732

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • METAvivor Research and Support, Inc

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2036
Study completion
2036
First posted
Jul 28, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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