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)

NCT07475923 | Withdrawn

• 2 other identifiers: 2025-1745NCI-2026-01855
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; ctDNA; MRD; Molecular Surveillance; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (6)

Arm A

Participants in Arm A are receiving neoadjuvant therapy (treatment before breast surgery)

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.

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).

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).

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).

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.

Diagnostic Test: Blood draw for the laboratory assessment; Drug: Neoadjuvant treatment

Interventions

Blood draw for the laboratory assessment DIAGNOSTIC_TEST

Blood will be drawn up to every cycle during neoadjuvant treatment

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Neoadjuvant treatment DRUG

Given by IV

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MD Anderson Cancer Center

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Serial blood samples to measure ctDNA and describe the dynamic changes of MRD using an ultrasensitive tumor informed assay during the spectrum of diagnosis, treatment and surveillance of early breast cancer.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Combined Modality Therapy; Therapeutics

Study Officials

• Carlos H Barcenas, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: April 9, 2026
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)