Status:
RECRUITING
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
Lead Sponsor:
Tempus AI
Conditions:
Breast Cancer
TNBC - Triple-Negative Breast Cancer
Eligibility:
All Genders
18-99 years
Brief Summary
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the canc...
Eligibility Criteria
Inclusion
- All Cohorts:
- Willing and able to participate in the research and provide biospecimens
- Willing and able to provide informed consent
- Must be diagnosed with breast cancer
- Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-
- A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
- Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
- Cohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.
- Cohort 1C: Triple Negative Breast Cancer
- 1\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).
- Cohort 2: Adjuvant Therapy / Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-
- A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
- Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
- Have undergone curative intent surgery with no clinical evidence of disease.
- Cohort 2B: HER2+
- A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)
- Have undergone curative intent surgery with no clinical evidence of disease.
- Cohort 2C: Triple Negative Breast Cancer
- A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)
- Have undergone curative intent surgery with no clinical evidence of disease.
- Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)
- A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).
- No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.
- Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
Exclusion
- Not willing or able to adhere with the study procedures
- Active secondary malignancy
- Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.
Key Trial Info
Start Date :
October 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07211178
Start Date
October 27 2025
End Date
December 1 2033
Last Update
January 9 2026
Active Locations (1)
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1
PIH Health Whittier Hospital
Whittier, California, United States, 90602