Status:
RECRUITING
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Hainan Medical University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuva...
Detailed Description
The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study obje...
Eligibility Criteria
Inclusion
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years old
- ECOG score 0-1
- Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer
- Left ventricular ejection fraction (LVEF) ≥ 50%
- 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females\<470ms
- The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L# PLT≥90 × 109/L# Hb≥90 g/L#Blood biochemistry: TBIL ≤ 2.5 × ULN# ALT and AST ≤ 2.5 × ULN# BUN and Cr ≤ 1.5 × ULN#
- For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment
- Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.
Exclusion
- Inflammatory breast cancer
- Metastatic tumor
- Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol.
- Active infections that require systemic treatment
- Has used any medication in this study within 14 days prior to enrollment
- Major surgery (excluding biopsy) performed within 14 days before enrollment
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2032
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06498154
Start Date
July 25 2024
End Date
June 30 2032
Last Update
December 19 2025
Active Locations (1)
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1
Tianjin medical university cancer institute and hospital
Tianjin, China