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Using ctDNA to monitor treatment response in triple-negative breast cancer

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

Observational Personalis Inc. · NCT06230185

This study is testing if checking for cancer DNA in the blood can help doctors see how well treatment is working for people with triple-negative breast cancer after they receive chemotherapy.

Quick facts

Study typeObservational
Enrollment422 (estimated)
Ages18 Years and up
SexFemale
SponsorPersonalis Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations14 sites (Tucson, Arizona and 13 other locations)
Trial IDNCT06230185 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the correlation between Molecular Residual Disease (MRD) detection using circulating tumor DNA (ctDNA) and pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in patients with stage I-III triple-negative breast cancer (TNBC). It employs next-generation sequencing technology to analyze cfDNA from blood samples and tumor tissue to create a personalized panel for MRD detection. The goal is to improve the understanding of MRD and enhance disease outcomes for future patients undergoing NAC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically documented stage I-III triple-negative breast cancer scheduled to undergo neoadjuvant chemotherapy.

Not a fit: Patients with stage IV breast cancer or those receiving concurrent anti-neoplastic therapy for another malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate monitoring of treatment response and improved outcomes for patients with TNBC.

How similar studies have performed: Other studies utilizing ctDNA for monitoring treatment response have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6).
2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
3. Be informed of the investigational nature of the study and all pertinent aspects of the trial.
4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
5. Be ≥ 18years of age.
6. Patient who are scheduled to start NAC.
7. Be willing to provide blood samples before and during treatment.
8. Have available biopsy tissue.

Exclusion Criteria:

1. Receiving concurrent anti-neoplastic therapy for another malignancy.
2. Stage IV disease.
3. Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy.
4. History of allogeneic bone marrow or organ transplant.
5. Blood transfusion within two weeks before collection of blood for central ctDNA testing.
6. Started systemic therapy for their breast cancer.
7. Pregnancy

Where this trial is running

Tucson, Arizona and 13 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 TNBC - Triple-Negative Breast CancerMinimal Residual DiseasectDNALiquid BiopsyBreast CancerMRDNACTNBC
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.