Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia

Study Overview
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Brief Summary
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This is a cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.

Detailed Description
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Breast cancer is a major public health problem, being the most common cancer in women worldwide. Breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. However, accurate assessment and prediction of the response is a major challenge. Circulating tumor DNA (ctDNA) has shown promise in the detection of breast cancer and clinical and cancer outcomes. This study aims to evaluate a possible correlations between ctDNA levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer. In order to start ctDNA surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.

Official Title
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Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Other: ctDNA level during neoadjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Information to the patient and signed informed consent; Locally advanced breast cancer that is a candidate for neoadjuvant therapy; Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2. Exclusion Criteria: Metastatic breast cancer (Stage IV); Additional invasive malignant disease; Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements; Presents any organic condition that makes it impossible to carry out chemotherapy treatment; Pregnant or lactating women Received previous treatment for breast cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer<br>Breast cancer patients who are currently receiving neoadjuvant therapy | Other: ctDNA level during neoadjuvant chemotherapy<br>* ctDNA samples will be collected from patients at baseline, during neoadjuvant therapy (every 15 days) and before the surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of circulating DNA(ctDNA) | Circulating tumor DNA (ctDNA) levels will be measured each 15 days until end of neoadjuvant therapy, through peripheral blood collection | From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline ctDNA alterations to end of neoadjuvant treatment | The percentage of patients with ctDNA alterations will be provided over time of neoadjuvant treatment to characterize the biological evolution of the disease in each patient. The association of these alterations with clinical outcomes will also be provided. | Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Liquid Biopsy, ctDNA, Pathologic complete response