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)

To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Observational Study; MRD; ctDNA; Molecular Surveillance
• Intervention / Treatment: Diagnostic test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

MD Anderson Cancer Center

Description

Eligibility Criteria

• Men or women who have a diagnosis of histological confirmed EBC (stage I, II or III) of any histopathology and any subtype (hormone-receptor positive or negative, HER2-positive, or negative).
• Have tumor tissue available of sufficient quality for processing by Myriad Genetics.
• Participant must be willing to provide serial blood samples at specific timepoints specific for each subgroup of interest per the Schedule of Activities
• Age ≥18 years at enrollment
• Arm A: Participants undergoing neoadjuvant systemic therapy: those with newly diagnosed untreated EBC of any subtype, stage I-II-II, who are scheduled to receive neoadjuvant systemic therapy of any type (i.e. chemotherapy, targeted therapy, immunotherapy, endocrine therapy) including a combination of agents, prior to undergoing breast surgery
• Arm B: Participants with TNBC or HER2-positive EBC (T1a, T1b, N0): those with newly diagnosed and untreated TNBC or HER2-positive EBC who have a plan to undergo upfront breast surgery as part of their standard of care treatment
• Arm C: Participants who receive an adjuvant CDK4/6-inhibitor (i.e., abemaciclib or ribociclib): those who have a diagnosis of hormone-receptor positive, HER2-negative, stage I-II-III EBC who have a plan to receive adjuvant abemaciclib or adjuvant ribociclib as part of their standard of care treatment
• Arm D: Participants who receive an adjuvant PARP-inhibitor (i.e., olaparib): those who have a germline pathogenic mutation (i.e. BRCA) and a diagnosis of hormone-receptor positive or negative, HER2-negative, stage I-II-III EBC, and have a plan to receive an adjuvant PARPinhibitor as part of their standard of treatment plan
• Arm E: Participants who develop ipsilateral locoregional recurrence (ILRR): those who have a diagnosis of EBC of any subtype, stage I-II-II and have completed local therapy (i.e. breast surgery and/or radiation therapy) and develop biopsy-proven locoregional disease recurrence in the ipsilateral breast and/or ipsilateral regional nodal basins
• Arm F: Participants who completed local therapy and are 5 or more years out from breast surgery: those who have a diagnosis of EBC of any subtype, stage I-II-II, and have completed local therapy (i.e. breast surgery and/or radiation therapy), and are 5 or more years out from local therapy and do not have clinical evidence of disease

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm A; Participants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery)	Diagnostic test: Blood draw for the laboratory assessment; Blood will be drawn up to every cycle during neoadjuvant treatment; Drug: Neoadjuvant treatment; Given by IV
Arm B; Participants in Arm B have early-stage triple negative breast cancer (TNBC) or HER2-positve (HER2+) breast cancer.	Diagnostic test: Blood draw for the laboratory assessment; Blood will be drawn up to every cycle during neoadjuvant treatment; Drug: Neoadjuvant treatment; Given by IV
Arm C; Participants in Arm C are receiving adjuvant therapy (treatment after breast surgery) with a CDK4/6-inhibitor (such as abemaciclib or ribociclib).	Diagnostic test: Blood draw for the laboratory assessment; Blood will be drawn up to every cycle during neoadjuvant treatment; Drug: Neoadjuvant treatment; Given by IV
Arm D; Participants in Arm D are receiving adjuvant therapy with a PARPinhibitor (such as olaparib).	Diagnostic test: Blood draw for the laboratory assessment; Blood will be drawn up to every cycle during neoadjuvant treatment; Drug: Neoadjuvant treatment; Given by IV
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).	Diagnostic test: Blood draw for the laboratory assessment; Blood will be drawn up to every cycle during neoadjuvant treatment; Drug: Neoadjuvant treatment; Given by IV
Arm F; Participants in Arm F completed treatment for EBC and had breast surgery 5 or more years ago.	Diagnostic test: Blood draw for the laboratory assessment; Blood will be drawn up to every cycle during neoadjuvant treatment; Drug: Neoadjuvant treatment; Given by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion; an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Carlos H Barcenas, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2026
• Primary Completion (Actual): April 9, 2026
• Study Completion (Actual): April 9, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Combined Modality Therapy; Neoadjuvant Therapy; Blood Specimen Collection
• Other Study ID Numbers: 2025-1745; NCI-2026-01855 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No