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Multi-center MRD Registry for Inflammatory Breast Cancer

NCT06966050 · M.D. Anderson Cancer Center
In plain English

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About this study
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.
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: \-
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-05
Estimated completion: 2032-05-31
Last updated: 2026-05-20
Interventions
Behavioral: Quality-of-life Questionnaire
Primary outcomes
  • European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (Through study completion; an average of 1 year)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactSadia Saleem, MD · contact · ssaleem@mdanderson.org · 281-566-1900
ContactAngela Alexander · contact · aalexand@mdanderson.org · 713-792-9137
InvestigatorSadia Saleem, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Multi-center MRD Registry for Inflammatory Breast Cancer · TrialPath