NCT06966050

Multi-center MRD Registry for Inflammatory Breast Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2030-05-31
• Completion: 2032-05-31
• First posted: 2025-05-11
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States