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

Instituto Brasileiro de Controle do Cancer

Status: Unknown

Conditions: Breast Neoplasm

Treatments: Other: ctDNA level during neoadjuvant chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05050890

32158620.0.0000.0072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

38 participants in 1 patient group

Breast cancer

Description:

Breast cancer patients who are currently receiving neoadjuvant therapy

Treatment:

Other: ctDNA level during neoadjuvant chemotherapy