MRD in High-risk EBC

NCT ID: NCT06566729

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Peripheral blood sample collection

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kunwei Shen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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RJBC2301

Identifier Type: -

Identifier Source: org_study_id

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