Status:
SUSPENDED
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
NA
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 v...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the pathologic response rate and presence of ctDNA post-neoadjuvant therapy in stage I-III breast cancer patients receiving neoadjuvant systemic therapy followed b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07136493
Start Date
January 12 2026
End Date
March 30 2028
Last Update
November 4 2025
Active Locations (5)
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1
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States, 85338
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
4
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States, 30265