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

NCT ID: NCT03881384

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ctDNA level

ctDNA level during neoadjuant chemotherapy

ctDNA level during neoadjuant chemotherapy

Intervention Type: OTHER

Draw blood from each enrolled patient every time before chemotherapy and measure the ctDNA level in plasma.

Interventions

ctDNA level during neoadjuant chemotherapy

Draw blood from each enrolled patient every time before chemotherapy and measure the ctDNA level in plasma.

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianjun He, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xian Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianjun He, PhD

Role: CONTACT

chinahjj@163.com

0086-13992808259

Facility Contacts

Jianjun He, PhD

Role: primary

chinahjj@163.com

0086-13992808259

Other Identifiers

XJTU1AF-CRF-2018-001

Identifier Type: -

Identifier Source: org_study_id