NCT05050890

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Instituto Brasileiro de Controle do Cancer · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
OTHER	ctDNA level during neoadjuvant chemotherapy	ctDNA samples will be collected from patients at baseline, during neoadjuvant therapy (every 15 days) and before the surgical procedure

Timeline

• Start date: 2020-08-05
• Primary completion: 2021-11-01
• Completion: 2022-02-28
• First posted: 2021-09-21
• Last updated: 2021-09-30

Locations

1 site across 1 country: Brazil