MRD in High-risk EBC

August 21, 2024 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

Application of Molecular Residual Disease in the Recurrence Monitoring and Response Predicting of High-risk Early Breast Cancer

This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
  2. HER2-positive breast cancer, lymph node metastasis≥4;
  3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;

Description

Inclusion Criteria:

  • Informed consent signed
  • Age ≥18 years old

  • Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions:

    1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
    2. HER2-positive breast cancer, lymph node metastasis≥4;
    3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;
  • ECOG 0-1
  • Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance

Exclusion Criteria:

  • Confirmed distant metastases site
  • History of other malignancy
  • Psychopaths or other reasons unable to comply with treatment
  • Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments
  • HIV carrier or HBC/HCV infected
  • Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival
Time Frame: 5 years after surgery
Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause
5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years after surgery
Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause
5 years after surgery
Lead time
Time Frame: 2 years after surgery
Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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