Breast Cancer
Conditions
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.
Interventions
BEHAVIORALQuality-of-life Questionnaire
Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
CONTACTSadia Saleem, MD
CONTACTAngela Alexander
PRINCIPAL_INVESTIGATORSadia Saleem, MD
M.D. Anderson Cancer Center
Outcome results
None listed