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

NCT03881384 | Unknown

• 1 other identifier: XJTU1AF-CRF-2018-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

ctDNA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ctDNA level

ctDNA level during neoadjuant chemotherapy

Other: ctDNA level during neoadjuant chemotherapy

Interventions

ctDNA level during neoadjuant chemotherapy OTHER

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

ctDNA level

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 that are considered possible candidates for neoadjuvant chemotherapy, by clinical-pathologic features.

You may qualify if:

• 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;

You may not qualify if:

• Known metastatic disease;
• With serious heart, lung, liver diseases;
• Poor cardiac function;
• Pregnant;
• Patients with other malignant tumor or treated before;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor biopsy specimen

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianjun He, PhD

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun He, PhD

CONTACT

0086-13992808259; chinahjj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)