Status:
COMPLETED
Impact of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
Brief Summary
The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor recept...
Detailed Description
We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated H...
Eligibility Criteria
Inclusion
- histologically proven primary breast cancer without distant metastatic lesions,
- HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization),
- initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST,
- a full course of standard neoadjuvant therapy before surgery
- complete clinicopathological characteristics and treatment information.
Exclusion
- do not plan or are unable to operate;
- with distant metastasis
- do not accept full cycles or standard neoadjuvant systemic therapy
- loss of clinicopathological characteristics and treatment information.
- with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non-tumor related diseases who could not tolerate comprehensive treatment such as surgery and chemotherapy
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
716 Patients enrolled
Trial Details
Trial ID
NCT06149377
Start Date
April 1 2012
End Date
May 31 2023
Last Update
December 13 2023
Active Locations (1)
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1
Chuan Wang
Fuzhou, Fujian, China, 350001