Status:

ACTIVE_NOT_RECRUITING

MRD in High-risk EBC

Lead Sponsor:

Shanghai Jiao Tong University School of Medicine

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

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 specime...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2028

Estimated Enrollment :

125 Patients enrolled

Trial Details

Trial ID

NCT06566729

Start Date

June 1 2023

End Date

April 1 2028

Last Update

August 22 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200025