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Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer

NCT07662252 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 186

Last updated 2026-06-23

No results posted yet for this study

Summary

The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help monitor and predict treatment responses in patients with breast cancer.

The study focuses on patients diagnosed with Stage II to III HER2-positive or Triple-Negative Breast Cancer (TNBC) who are scheduled to receive standard neoadjuvant therapy (systemic treatment administered before surgery). Because these breast cancer subtypes involve different standard treatment regimens, the study prospectively stratifies patients into three distinct treatment cohorts (Cohorts A, B, and C) to match routine clinical practice and align blood sampling with meaningful clinical milestones.

Conditions

  • Breast Cancer
  • Triple Negative Breast Cancer (TNBC)
  • HER2 + Breast Cancer

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-10-31
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662252 on ClinicalTrials.gov