Actively Recruiting
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-12-19
200
Participants Needed
1
Research Sites
413 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 neoadjuvant chemotherapy.
CONDITIONS
Official Title
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Initial treatment patients with ECOG score 0-1
- Clinical T1-2N0 HER2 positive (HR negative, HER2 IHC score 3+ or 2+ with positive ISH test) or triple negative invasive breast cancer
- Left ventricular ejection fraction (LVEF) 50% or higher
- QT interval (QTcF) less than 470 ms on 12 lead electrocardiogram
- Adequate organ function including blood counts and biochemistry within specified limits
- For women not menopausal or sterilized, agree to abstain or use effective contraception during and for at least 2 months after treatment
- Willing to provide informed consent and comply with study follow-up
You will not qualify if you...
- Inflammatory breast cancer
- Metastatic tumors
- Previous or current malignant tumors that may affect study safety
- Active infections requiring systemic treatment
- Use of any study medication within 14 days prior to enrollment
- Major surgery (excluding biopsy) within 14 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin medical university cancer institute and hospital
Tianjin, China
Actively Recruiting
Research Team
Z
ZHENGJUN YANG, MD
CONTACT
Q
QINGSONG PANG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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