Using blood-based tumor DNA (ctDNA) to find leftover breast cancer after treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, longitudinal project collects serial blood samples from people with early-stage and newly treated breast cancer to profile circulating tumor DNA (ctDNA) using next-generation sequencing. Patients are enrolled across defined cohorts (neoadjuvant high-risk HR+/HER2-, HER2+, and triple-negative, plus adjuvant/surveillance groups) and have periodic liquid biopsies without changes to their standard treatment. The goal is to see whether detecting minimal residual disease (MRD) in blood predicts cancer recurrence or indicates response to therapy. There are no experimental treatments — only blood draws and molecular testing to track tumor-derived DNA over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All Cohorts:

1. Willing and able to participate in the research and provide biospecimens
2. Willing and able to provide informed consent
3. Must be diagnosed with breast cancer

Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-

1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
2. 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-

1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
2. 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.
3. Have undergone curative intent surgery with no clinical evidence of disease.

Cohort 2B: HER2+

1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)
2. Have undergone curative intent surgery with no clinical evidence of disease.

Cohort 2C: Triple Negative Breast Cancer

1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)
2. Have undergone curative intent surgery with no clinical evidence of disease.

Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)

1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).
2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.
3. 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 Criteria:

1. Not willing or able to adhere with the study procedures
2. Active secondary malignancy
3. 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.

Where it's running

• Birmingham Hematology Associates
  Birmingham, Alabama, United States Recruiting
• PIH Health Whittier Hospital
  Whittier, California, United States Recruiting
• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting
• Southern Illinois Hospital Services
  Carbondale, Illinois, United States Recruiting
• Cancer Care Specialist of Illinois
  O'Fallon, Illinois, United States Recruiting
• Goshen Center for Cancer Care
  Goshen, Indiana, United States Recruiting

Study contacts

• Principal investigator: Michelle Ting-Lin, MD — Tempus AI
• Study coordinator: GEMINI Breast Clinical Study Manager
• Email: gemini-breast@tempus.com
• Phone: (833) 514-4187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.