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Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Sponsor
Zhiyong Yu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03688035
Collaborator
(none)
60
Enrollment
1
Location
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Breast cancer is the most common malignant tumor in women worldwide,and there exist a large part of patients need to receive neoadjuvant chemotherapy(NAC) before the curative surgery.Circulating tumor DNA(ctDNA) is the circulating free DNA in the blood that originates from cancers,and it can be detected by modern technologies in plasma.In this prospective study,investigators aim to observe the correlation between tumor response to neoadjuvant chemotherapy and ctDNA.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Women with node-positive breast cancer are at high risk for recurrence. Neoadjuvant chemotherapy is traditionally for locally advanced disease, converting an inoperable tumor to a resectable one.In the present study, investigators will focus on breast cancer patients whose primary tumors are large or have lymph node metastases and need to receive neoadjuvant chemotherapy from 2018 to 2019. Circulating tumor DNA(ctDNA) will be obtained from peripheral blood,and the blood samples will be taken before the neoadjuvant chemotherapy、during the chemotherapy、 before the surgery and post surgery visit (within 24 hours after surgery) .Investigators will collect tissue samples both from the breast lump biopsy and the curative surgery. Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to monitor the efficacy of neoadjuvant chemotherapy in breast cancer.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Study on the Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
    Anticipated Study Start Date :
    Sep 20, 2018
    Anticipated Primary Completion Date :
    Sep 20, 2019
    Anticipated Study Completion Date :
    Sep 20, 2019

    Outcome Measures

    Primary Outcome Measures

    1. dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes [From patients recruited into the research until the surgury complete ,assessed up to 26 weeks.]

      To assess the changes of ctDNA mutant copies during the process of our observation,and to find out the relationship between ctDNA and tumor response to neoadjuvant chemotherapy

    Secondary Outcome Measures

    1. disease free survival after surgery [Up to 5 years]

      To observe the duration from the end of curative surgery to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Female patients undergoing neoadjuvant chemotherapy

    • Age: 18-70 yrs

    • Any menopausal status

    • Any hormone receptor status

    • Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):

    • Locally advanced tumor

    • Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.

    Exclusion Criteria:

    • Failed to retain blood sample before NAC

    • Lost more than 2 blood samples during NAC

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong Cancer Hospital and Institute Jinan Shandong China

    Sponsors and Collaborators

    • Zhiyong Yu

    Investigators

    • Study Chair: Zhiyong Yu, PHD, Shandong Cancer Hospital and Institute
    • Principal Investigator: Zhaoyun Liu, MD, Shandong Cancer Hospital and Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhiyong Yu, Director of the Breast Surgery Ⅰ, Shandong Cancer Hospital and Institute
    ClinicalTrials.gov Identifier:
    NCT03688035
    Other Study ID Numbers:
    • ShandongCHI-08
    First Posted:
    Sep 27, 2018
    Last Update Posted:
    Sep 27, 2018
    Last Verified:
    Sep 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Sep 27, 2018