Multi-center MRD Registry for Inflammatory Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality-of-life Questionnaire.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.
Detailed description
Primary Objectives
-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).
Secondary Objectives
* To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants. * To evaluate the association of pre-surgery MRD to pathologic response. * To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results * To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally * To determine the median lead time between the first MRD-positive result and clinical recurrence. * To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.
Interventions
- Behavioral Quality-of-life Questionnaire
Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.
Primary outcome measures
- European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- Female or males ≥18 years of age with the ability to understand and sign a written
- Participants who have a clinical diagnosis of stage III or IV inflammatory breast cancer (IBC).
- Participants who are planning to have or already completed a minimum of one blood draw for Signatera testing, for which the result and clinical data can be deposited into the study database.
- Participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer.
- Participants must be English-speaking.
Exclusion criteria
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06966050 · 2025-0415 · NCI-2025-03109