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OpenTrials
Active, Not Recruiting

NCT Number: NCT06566729

MRD in High-risk EBC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Lead time

    Time frame: 2 years after surgery

    Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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