Multi-center MRD Registry for Inflammatory Breast Cancer

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06966050
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2025-04-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-02
• Study Start: 2025-05-05
• Study First Posted: 2025-05-11
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-25
• Primary Completion: 2030-05-31
• Study Completion: 2032-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire	Through study completion; an average of 1 year	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)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States