Study Stopped
Funding
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
3 other identifiers
interventional
350
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
May 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
March 5, 2026
March 1, 2026
1.9 years
August 10, 2025
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of patients that achieve a pathologic complete response and are circulating tumor deoxyribonucleic acid (ctDNA) detectable (Cohort 1)
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Up to 3 years after standard of care (SOC) surgery
ctDNA detection rate (Cohort 2)
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Before and after SOC surgery (up to 3 years)
Secondary Outcomes (6)
ctDNA detection rate 1
Before and after adjuvant chemotherapy and/or radiation therapy (up to 3 years)
ctDNA detection rate 2
Up to 3 years post-definitive treatment
Recurrence free survival (RFS)
Post-neoadjuvant treatment and post-surgery (up to 3 years)
ctDNA level
Up to 3 years after SOC surgery
Rate of concordance between ctDNA changes on systemic treatment and clinical response
Up to 3 years after SOC surgery
- +1 more secondary outcomes
Study Arms (2)
Cohort 1 (blood collection for ctDNA testing - 1)
EXPERIMENTALPatients undergo collection of blood samples for ctDNA testing at 14-21 days post cycle 1, day 1 of SOC neoadjuvant chemotherapy, on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
Cohort 2 (blood collection for ctDNA testing -2)
EXPERIMENTALPatients undergo collection of blood samples for ctDNA testing on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
Interventions
Undergo collection of blood samples for ctDNA testing
Ancillary studies
Ancillary studies
Eligibility Criteria
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
- +1 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265, United States
City of Hope at Chicago
Zion, Illinois, 60099, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose G Bazan
City of Hope Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2025
First Posted
August 22, 2025
Study Start
May 12, 2026
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2028
Last Updated
March 5, 2026
Record last verified: 2026-03