Breast CancerNCT06966050
Multi-center MRD Registry for Inflammatory Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To collect data from participants with IBC who may have had MRD testing and may have surgery in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Quality-of-life Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 31 May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Sadia Saleem, MD, 281-566-1900, ssaleem@mdanderson.org
Angela Alexander, 713-792-9137, aalexand@mdanderson.org
About this study
To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.
Read the 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
- Being tested
- Quality-of-life Questionnaire
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-life QuestionnaireBehavioural
Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants will fill out a quality-of-life questionnaire and complete a MRD test. Receives: Behavioral: Quality-of-life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire
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)
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start5 May 2025
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadia Saleem, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966050
- Sponsor's protocol ID
- 2025-0415
- Other IDs
- NCI-2025-03109
- Status last verified
- May 2026
- First submitted
- 25 Apr 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center MRD Registry for Inflammatory Breast Cancer
- ClinicalTrials.gov ID
- NCT06966050
- Acronym / sponsor ID
- 2025-0415
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Quality-of-life QuestionnaireParticipants will fill out a quality-of-life questionnaire and complete a MRD test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-life QuestionnaireParticipants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete. | Behavioural | Group 1 |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sadia Saleem, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadia Saleem, MD (281-566-1900, ssaleem@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.