RecruitingRecruiting
Multi-center MRD Registry for Inflammatory Breast Cancer
NCT06966050 · M.D. Anderson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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