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Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer

NCT07136493 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-03-05

No results posted yet for this study

Summary

This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer. MRD refers to a very small number of tumor cells that remain in the body during or after treatment. ctDNA refers to small pieces of DNA that are released into a person's blood by tumor cells as they die. Management of patients after cancer surgery remains a clinical dilemma, particularly for cancer detected at earlier stages as many patients are cured by surgery alone. This results in very large clinical trials required to demonstrate a modest benefit from treatment. Using ctDNA MRD testing in early-stage breast cancer patients receiving standard treatment may help researchers identify groups that would benefit from additional therapy, leading to better outcomes.

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Estrogen Receptor-Positive Breast Carcinoma
  • HER2-Negative Breast Carcinoma
  • HER2-Positive Breast Carcinoma
  • Triple-Negative Breast Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples for ctDNA testing

PROCEDURE

Biospecimen Collection

Undergo possible collection of tissue

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Jose G Bazan · City of Hope Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2028-03-30
Completion
2028-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136493 on ClinicalTrials.gov