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
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