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

Launched by CITY OF HOPE MEDICAL CENTER · Aug 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to check for tiny amounts of breast cancer cells that might remain in the body after treatment, called minimal residual disease (MRD). To do this, the study looks for small pieces of tumor DNA that circulate in the blood, known as circulating tumor DNA (ctDNA). Detecting these DNA pieces could help doctors find out which patients with early-stage breast cancer might benefit from extra treatment after surgery, potentially improving outcomes while avoiding unnecessary therapy for those already cured.

The trial is open to adults diagnosed with stage I to III breast cancer, including all common types such as hormone receptor-positive, HER2-positive, and triple-negative breast cancer. Participants will need to provide blood samples and may be asked to share tissue samples from their tumor or surgery. The study includes people who are about to start treatment, either surgery alone or chemotherapy followed by surgery. If you join, you can expect regular blood tests to monitor for these tumor DNA fragments and medical record reviews, but no experimental treatments are given directly as part of this study. This trial aims to better tailor breast cancer care by using blood tests to guide decisions after initial treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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