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

NCT ID: NCT05050890

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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Breast Neoplasm

Keywords

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Breast Cancer Liquid Biopsy ctDNA Pathologic complete response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer

Breast cancer patients who are currently receiving neoadjuvant therapy

ctDNA level during neoadjuvant chemotherapy

Intervention Type OTHER

ctDNA samples will be collected from patients at baseline, during neoadjuvant therapy (every 15 days) and before the surgical procedure

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Brasileiro de Controle do Cancer

OTHER

Sponsor Role lead

Responsible Party

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Camila Giro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camila Giro, MD

Role: PRINCIPAL_INVESTIGATOR

IBCC Oncologia

Locations

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IBCC Oncologia

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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32158620.0.0000.0072

Identifier Type: -

Identifier Source: org_study_id