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Recruiting

NCT Number: NCT06966050

Multi-center MRD Registry for Inflammatory Breast Cancer

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Quality-of-life Questionnaire

Behavioral

Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.

Primary outcomes

  1. European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Alexander

CONTACT

[email protected]

713-792-9137

Sadia Saleem, MD

CONTACT

[email protected]

281-566-1900

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
May 11, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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