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Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

A

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Sentinel Lymph Node
Breast Cancer

Treatments

Diagnostic Test: mapping agent
Procedure: neoadjuvant chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT04156841
KY20192114-C-1

Details and patient eligibility

About

Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.

Enrollment

21,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • breast cancer confirmed by fine needle aspiration or biopsy
  • SLNB with or without axillary lymph node dissection
  • receiving conventional systematic treatment or regional treatment
  • complete medical record.

Exclusion criteria

  • IV stage breast cancer
  • combined with secondary invasive malignant tumor
  • diagnosed with other serious disease, including congestive heart failure (NYHA cardiac function grade II, III, IV) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months
  • difficulty breathing at rest or need oxygen therapy
  • severe infection
  • uncontrolled diabetes
  • serious psychological or mental disorders
  • poor compliance.

Trial design

21,000 participants in 4 patient groups

performed SLNB using a single mapping agent
Treatment:
Diagnostic Test: mapping agent
performed SLNB by combination of blue dye and radiotracer
Treatment:
Diagnostic Test: mapping agent
underwent SLN surgery receiving neoadjuvant chemotherapy
Treatment:
Procedure: neoadjuvant chemotherapy
underwent SLN surgery not receiving neoadjuvant chemotherapy
Treatment:
Procedure: neoadjuvant chemotherapy

Trial contacts and locations

1

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Central trial contact

Juliang Zhang

Data sourced from clinicaltrials.gov

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