Status:
UNKNOWN
Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy
Lead Sponsor:
Peking University
Conditions:
Invasive Breast Cancer
Eligibility:
FEMALE
Up to 70 years
Brief Summary
This is a prospective, single-center, non-randomized, non-controlled observational study.
Detailed Description
The panel of the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 strongly believed that sentinel lymph node biopsy to be appropriate and favored...
Eligibility Criteria
Inclusion
- Invasive breast cancer diagnosed with core needle needle biopsy;
- Staging cT1b-2N0M0;
- ER/PR positive cells ratio \<10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
- Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
- With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
- Voluntarily join the study and sign an informed consent form.
Exclusion
- History of malignant tumors.
- With chemotherapy contraindications.
- Recieved any form of surgery of primary tumor or axillary lymph nodes.
- Refuse neoadjuvant chemotherapy.
- Refuse assessment examinations.
- Refuse to join the study.
Key Trial Info
Start Date :
December 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT03381092
Start Date
December 22 2017
End Date
June 30 2022
Last Update
November 29 2021
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142