Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:

Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients During Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03881384
• Other study ID #: XJTU1AF-CRF-2018-001
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jianjun He, PhD
• Phone: 0086-13992808259
• Email: chinahjj[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.

Description:

Breast cancer is the most common malignant tumor in women worldwide, and chemotherapy is still the main method of breast cancer treatment. And for locally advanced breast cancer patients, neoadjuvant chemotherapy can further improve treatment efficacy, improve prognosis and increase the rate of breast conserving surgery. The persistence of a minimal residual disease at distant sites after the treatment of a localized breast cancer is a key parameter for posttreatment survival but cannot be reliably assessed by the current biological or radiological tools. Therefore, the prediction of the chemotherapy efficacy is very important. ctDNA, corresponds to fragmented DNA released into the blood stream by tumor masses, the detection and quantification of circulating tumor DNA (ctDNA) is a very promising tool that can assess tumor burden, response to therapy, and minimal residual disease. In this study, we wil collect breast cancer cases treated with neoadjuvant chemotherapy, draw blood and evaluate the efficacy each time before chemotherapy and after surgery, then measure the concentration of ctDNA in each sample. We will also analyze the demographic data,basic treatment and follow-up data including relapse, metastasis and survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer;

• Tumor size = 0.5cm (clinical or radiographic measurements);

• Any nodal status allowed;

• Age > 18 years old;

• Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician;

• ECOG score<=2;

Exclusion Criteria:

• Known metastatic disease;

• With serious heart, lung, liver diseases;

• Poor cardiac function;

• Pregnant;

• Patients with other malignant tumor or treated before;

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• ctDNA level during neoadjuant chemotherapy
Draw blood from each enrolled patient every time before chemotherapy and measure the ctDNA level in plasma.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of circulating DNA(ctDNA)	Take the blood each time before chemtherapy and measure the concentration of ctDNA	From date of neoadjuvant chemotherapy decided until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months