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RecruitingObservational

Multi-center MRD Registry for Inflammatory Breast Cancer

NCT ID: NCT06966050Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-05-20

Summary

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.

Arms & interventions

  • BehavioralQuality-of-life Questionnaire

    Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.

Outcome measures

Primary

  • European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire

    European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Score scale: (1-30 questions to assess the impact of participants quality of life)

    Time frame: Through study completion; an average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years and older
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: \-

Study locations (1)

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Sadia Saleem, MD · Contact
Angela Alexander · Contact
Sadia Saleem, MD · Principal Investigator