MRD in High-risk EBC

NCT06566729 | Active Not Recruiting

• 1 other identifier: RJBC2301
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

MRD; breast cancer; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  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 Outcomes (2)

• Overall survival

  5 years after surgery

• Lead time

  2 years after surgery

Interventions

Peripheral blood sample collection OTHER

In this study, peripheral blood samples would be collected before adjuvant chemotherapy, after adjuvant chemotherapy and every 3 months thereafter until 2 years after surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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:
• Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
• HER2-positive breast cancer, lymph node metastasis≥4;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 22, 2024
• Study Start: June 1, 2023
• Primary Completion: September 30, 2024
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)