NCT07136493Withdrawn
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
Evaluation of Circulating Tumor DNA Based Minimal Residual Disease Detection in Early Stage Breast Cancer Patients: A Prospective Study
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Reason given: Funding This study has been closed at City of Hope at the request of the Sponsor due to delays and changes in study timeline.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 10 Aug 2025
- Start date
- 12 May 2026
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07136493
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent invasive malignancy (unless disease free > 5 years)
Other
- Ductal carcinoma in situ
- Inability to safely provide sequential blood samples
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | United States | Unknown status |
| CTCA at Western Regional Medical Center | Goodyear | United States | Unknown status |
| City of Hope at Irvine Lennar | Irvine | United States | Unknown status |
| City of Hope Atlanta Cancer Center | Newnan | United States | Unknown status |
| City of Hope at Chicago | Zion | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.