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

• Conditions: Breast Neoplasm
• Interventions: Other: ctDNA level during neoadjuvant chemotherapy

• Registration Number: NCT05050890
• Lead Sponsor: Instituto Brasileiro de Controle do Cancer

Brief 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.

Study Timeline

• Study Start: 2020-08-05
• Status Verified: 2021-08
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-30
• Primary Completion: 2021-11-01
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 38

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer	ctDNA level during neoadjuvant chemotherapy	Breast cancer patients who are currently receiving neoadjuvant therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline ctDNA alterations to end of neoadjuvant treatment	Up to approximately 7 months starting from Baseline until 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.

Trial Locations

Locations (1)

IBCC Oncologia; 🇧🇷 Sao Paulo, SP, Brazil