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

NCT05050890 | Unknown

• 1 other identifier: 32158620.0.0000.0072
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm

Keywords

Breast Cancer; Liquid Biopsy; ctDNA; Pathologic complete response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline ctDNA alterations to end of neoadjuvant treatment

  Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment

Study Arms (1)

Breast cancer

Breast cancer patients who are currently receiving neoadjuvant therapy

Other: ctDNA level during neoadjuvant chemotherapy

Interventions

ctDNA level during neoadjuvant chemotherapy OTHER

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

Breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with breast cancer who are considered possible candidates for neoadjuvant chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead

Study Sites (1)

IBCC Oncologia

São Paulo, São Paulo, 03102-002, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Camila Giro, MD

  IBCC Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: August 5, 2020
• Primary Completion: November 1, 2021
• Study Completion: February 28, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)