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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFederico II University

About this trial

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.

Eligibility criteria

Qualifiers

Patients with documented stage II-III HER2+ or TNBC and fit candidates for NAT. 2. In TNBC group, confirmed negative ER, PR and HER2 disease by local testing on primary disease specimen: tumor must be negative ER, PR, and HER2 defined by immunohistochemistry (IHC) according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al., 2020; Wolff et al., 2023). 3. In HER2+ group, Confirmed HER2+ disease by local testing on primary disease specimen: tumour must be HER2+ according to ASCO/CAP 2023 guidelines for HER2 testing (Wolff et al., 2023). 4. Patients with measurable disease; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathological criteria for TNBC and HER2+. 5. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. 6. Patients with breast cancer are eligible for surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status≤2.

Disqualifiers

1. Patients with bilateral invasive BC. 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1_cN2a).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

186 Participants
are grouped into 3 trial groups

Locations

This trial has no locations

Sponsors and collaborators