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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Oncology
  Tucson, Arizona, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• George Washington University
  Washington D.C., District of Columbia, United States Recruiting
• Mount Sinai Medical Center of Florida
  Miami Beach, Florida, United States Recruiting
• Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
  St. Petersburg, Florida, United States Recruiting
• Illinois Cancer Care
  Peoria, Illinois, United States Recruiting

Study contacts

• Principal investigator: Pavani Chalasani — George Washington University
• Study coordinator: Soumya Chappidi
• Email: schappidi@criteriuminc.com
• Phone: 484-704-2599

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• ctDNA blood test to spot buried cancer after surgery or treatment in colorectal cancer

  A blood test that looks for specific KRAS mutations in circulating tumor DNA to see if colorectal cancer has left residual disease or is likely to relapse.

  Recruiting Masaryk Memorial Cancer Institute · Brno, Czech Republic · NCT07895459

• MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC

  This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07894458

• Imaging Test for Metastatic Urothelial and Breast C cancers and NSCLC

  This imaging study tests how well the imaging agent works in people with metastatic urothelial cancer, various breast cancers, or NSCLC.

  Recruiting at 4 sites Early Phase 1 RayzeBio, Inc. · St Leonards, New South Wales and 5 other locations · NCT07671092

• Radiotherapy with chemotherapy plus adebrelimab and bevacizumab for TNBC with brain metastases

  This phase II study tests a combination of radiotherapy, cisplatin or carboplatin, adebrelimab, and bevacizumab in adults with triple-negative breast cancer that has spread to the brain.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07638852

• First-line therapy for advanced TNBC with QL1706, plus anlotinib and nab-paclitaxel

  This study tests whether a combination of QL1706 with anlotinib and nab-paclitaxel can help people with newly diagnosed, advanced triple-negative breast cancer.

  Recruiting Phase 2 Jiangsu Cancer Institute & Hospital · Nanjing, Jiangsu · NCT07601178

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.