Multi-center MRD Registry for Inflammatory Breast Cancer
NCT ID: NCT06966050
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-05-05
2032-05-31
Brief Summary
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Detailed Description
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-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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Participants will fill out a quality-of-life questionnaire and complete a MRD test.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sadia Saleem, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Sadia Saleem, MD
Role: primary
Angela Alexander
Role: backup
Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2025-03109
Identifier Type: OTHER
Identifier Source: secondary_id
2025-0415
Identifier Type: -
Identifier Source: org_study_id