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

Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies

Observational Tempus AI · NCT07211178

This research will test whether a simple blood test that looks for tiny bits of tumor DNA can tell if people treated for breast cancer (including HR+/HER2-, HER2+, and triple-negative) still have leftover cancer or are at risk of recurrence.

Quick facts

Study typeObservational
Enrollment900 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorTempus AI Industry-sponsored
Locations12 sites (Birmingham, Alabama and 11 other locations)
Trial IDNCT07211178 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with a diagnosis of breast cancer treated with curative intent (stage I-III), including HR+/HER2-, HER2+, and triple-negative subtypes, who can provide informed consent and serial blood samples.

Not a fit: Patients with metastatic (stage IV) disease or those unwilling/unable to provide repeat blood samples are unlikely to benefit from this observational MRD protocol.

Why it matters

Potential benefit: If successful, this approach could allow earlier detection of recurrence and help personalize follow-up or additional treatment decisions.

How similar studies have performed: Previous research has shown promising results that ctDNA can predict recurrence in breast cancer, though using ctDNA routinely to guide clinical care is still being validated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerTNBC - Triple-Negative Breast CancerHR Positive/HER-2 Negative Breast CancerHER2 + Breast CancerEarly Stage Breast CancerMinimal Residual DiseaseMRDNext generation sequencing
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.