Multi-center MRD Registry for Inflammatory Breast Cancer

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Breast Cancer

Treatments

Behavioral: Quality-of-life Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT06966050

2025-0415

NCI-2025-03109 (Other Identifier)

Details and patient eligibility

About

To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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