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

Withdrawn before enrolling · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT07136493
Run by: City of Hope Medical Center
People needed: 0
Starts: 2026-05-12
Expected to finish: 2026-06-16
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented written informed consent of the participant
Age ≥ 18 years
Diagnosis of stage I-III breast cancer (any gender)
Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
Willingness to:
Provide blood samples
Provide archival tumor tissue sample (only necessary for Cohort 2 if analysis of surgical tissue was not successful)
Provide tumor tissue sample from resection/surgery (only necessary for Cohort 1 if analysis of surgical tissue was not successful)
Permit medical record review
Fall into one of the following categories defined below: Cohort 1, Subgroup A or B OR Cohort 2
COHORT 1: Must have archival diagnostic tissue available
COHORT 1: Scheduled to undergo, but has not yet begun, neoadjuvant systemic therapy followed by curative resection
COHORT 1 (Subgroup A): HER2+ by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines (any ER/PR status)
COHORT 1 (Subgroup B): Triple negative (ER, PR and HER2 negative). Defined as ER and PR ≤ 10% by immunohistochemistry (IHC) and HER2 negative, by current ASCO/CAP guidelines
COHORT 2: Scheduled to undergo upfront curative surgical resection with or without adjuvant chemotherapy followed by adjuvant endocrine therapy
COHORT 2: ER+/any PR/HER2- (ER positive defined as ER > 10% by IHC)

You may not qualify if…

Ductal carcinoma in situ
Inability to safely provide sequential blood samples
Prior or concurrent invasive malignancy (unless disease free > 5 years)
An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
A direct study team member
Inability to give informed consent

Where it is running

CTCA at Western Regional Medical Center — Goodyear, Arizona, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
City of Hope at Irvine Lennar — Irvine, California, United States
City of Hope Atlanta Cancer Center — Newnan, Georgia, United States
City of Hope at Chicago — Zion, Illinois, United States

Full record on ClinicalTrials.gov

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