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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05050890
Other study ID # 32158620.0.0000.0072
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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