Clinical trial · Observational
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
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
NCT05964504CI-TRIAL-00125311recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Specimen | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Initial Cohort
- description
- 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.
- interventionNames
- Procedure: Blood Specimen
Primary outcomes (4)
- measure
- Feasibility of registry
- timeFrame
- Up to 2 years
- description
- 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
- measure
- Proportion of patients with measurable versus unmeasurable disease
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.