Molecular SurveillanceNCT07475923
Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study)
An observational study of Molecular Surveillance and Breast Cancer, run by M.D. Anderson Cancer Center.
Trial summary
To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Molecular Surveillance, Breast Cancer, ctDNA
- What is being tested?
- Blood draw for the laboratory assessment and Neoadjuvant treatment
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2026to 9 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- Participants with distant cancer metastases (beyond locoregional disease recurrence)
- Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
- Current or recent (within the last year) diagnosis of another primary malignancy (except skin cancer and non-invasive cancer)
- Personal history of allogenic bone marrow or organ transplant
- Participants who are pregnant
About this study
To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.
Read the detailed description
Primary Objectives To describe the dynamic changes of ctDNA by binary MRD status (positive/negative) using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
Secondary Objectives To describe the dynamic changes of ctDNA by continuous quantitative tumor fraction using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
- Conditions
- Molecular Surveillance, Breast Cancer, ctDNA, MRD, Observational Study
- Being tested
- Blood draw for the laboratory assessment, Neoadjuvant treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the laboratory assessmentDiagnostic test
Blood will be drawn up to every cycle during neoadjuvant treatment
Neoadjuvant treatmentDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Participants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery) Receives: Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment | |
| Arm B | Participants in Arm B have early-stage triple negative breast cancer (TNBC) or HER2-positve (HER2+) breast cancer. Receives: Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment | |
| Arm C | Participants in Arm C are receiving adjuvant therapy (treatment after breast surgery) with a CDK4/6-inhibitor (such as abemaciclib or ribociclib). Receives: Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment | |
| Arm D | Participants in Arm D are receiving adjuvant therapy with a PARPinhibitor (such as olaparib). Receives: Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment | |
| Arm E | Participants in Arm E have a history of EBC and have developed ipsilateral locoregional recurrence (the cancer has returned in the same area where the original tumor was). Receives: Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment | |
| Arm F | Participants in Arm F completed treatment for EBC and had breast surgery 5 or more years ago. Receives: Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 posted17 Mar 2026
- Study start9 Apr 2026
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Why it stopped: PI requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular SurveillanceStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos H Barcenas, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475923
- Sponsor's protocol ID
- 2025-1745
- Other IDs
- NCI-2026-01855
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study)
- ClinicalTrials.gov ID
- NCT07475923
- Acronym / sponsor ID
- 2025-1745
- Conditions
- Molecular Surveillance, Breast Cancer, ctDNA, MRD, Observational Study
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI requested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 17 Mar 2026 (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 learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.
Detailed description
Primary Objectives To describe the dynamic changes of ctDNA by binary MRD status (positive/negative) using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
Secondary Objectives To describe the dynamic changes of ctDNA by continuous quantitative tumor fraction using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Diagnostic Test: Blood draw for the laboratory assessment, Drug: Neoadjuvant treatmentParticipants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery) |
| Arm B | – | Diagnostic Test: Blood draw for the laboratory assessment, Drug: Neoadjuvant treatmentParticipants in Arm B have early-stage triple negative breast cancer (TNBC) or HER2-positve (HER2+) breast cancer. |
| Arm C | – | Diagnostic Test: Blood draw for the laboratory assessment, Drug: Neoadjuvant treatmentParticipants in Arm C are receiving adjuvant therapy (treatment after breast surgery) with a CDK4/6-inhibitor (such as abemaciclib or ribociclib). |
| Arm D | – | Diagnostic Test: Blood draw for the laboratory assessment, Drug: Neoadjuvant treatmentParticipants in Arm D are receiving adjuvant therapy with a PARPinhibitor (such as olaparib). |
| Arm E | – | Diagnostic Test: Blood draw for the laboratory assessment, Drug: Neoadjuvant treatmentParticipants in Arm E have a history of EBC and have developed ipsilateral locoregional recurrence (the cancer has returned in the same area where the original tumor was). |
| Arm F | – | Diagnostic Test: Blood draw for the laboratory assessment, Drug: Neoadjuvant treatmentParticipants in Arm F completed treatment for EBC and had breast surgery 5 or more years ago. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Participants with distant cancer metastases (beyond locoregional disease recurrence)
- Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
- Current or recent (within the last year) diagnosis of another primary malignancy (except skin cancer and non-invasive cancer)
- Personal history of allogenic bone marrow or organ transplant
- Participants who are pregnant
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 |
|---|---|---|
| Blood draw for the laboratory assessmentBlood will be drawn up to every cycle during neoadjuvant treatment | Diagnostic test | Arm A, Arm B, Arm C, Arm D, Arm E, Arm F |
| Neoadjuvant treatmentGiven by IV | Drug | Arm A, Arm B, Arm C, Arm D, Arm E, Arm F |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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. This study is not recruiting at the moment.
Carlos H Barcenas, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Molecular Surveillance and Breast Cancer, run by M.D. Anderson Cancer Center.
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 0 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (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 16 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.