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

Breast Neoplasm Clinical Trial

— GIRO_ctDNA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05050890
• Other study ID #: 32158620.0.0000.0072
• Status: Active, not recruiting
• Start date: August 5, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2021
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: February 28, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	IBCC Oncologia	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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