Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Brea… (NCT07136493) | Clinical Trial Compass
WithdrawnNot Applicable
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
Stopped: Funding This study has been closed at City of Hope at the request of the Sponsor due to delays and changes in study timeline.
United States0Started 2026-05-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 seque…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients that achieve a pathologic complete response and are circulating tumor deoxyribonucleic acid (ctDNA) detectable (Cohort 1)
Timeframe: Up to 3 years after standard of care (SOC) surgery
2
ctDNA detection rate (Cohort 2)
Timeframe: Before and after SOC surgery (up to 3 years)