Actively Recruiting
Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-12
35
Participants Needed
3
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged between 18 and 75 years old
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Histologically or pathologically confirmed invasive ductal carcinoma of the breast meeting specific tumor size and grade criteria
- Tumor is hormone receptor-positive (ER ≥1%), HER2-negative (FISH ratio ≤1.8 or IHC 0 or 1+), and combined positive score (CPS) ≥10
- No prior cancer treatment
- Adequate organ function including blood counts, liver and kidney function, heart function, and ECG results within defined limits
- Use of effective contraception during treatment and for 6 months after if premenopausal or not surgically sterilized
- Voluntary participation with informed consent, good compliance, and willingness for follow-up
You will not qualify if you...
- Stage IV breast cancer
- Inflammatory breast cancer
- Previous anti-tumor treatment or radiotherapy for any malignant tumor except certain cured cancers
- Participation in other anti-tumor clinical trials
- Major surgery unrelated to breast cancer within 4 weeks before study drug administration or incomplete recovery from such surgery
- Severe heart diseases including heart failure, significant arrhythmias, angina needing treatment, severe valvular disease, myocardial infarction, or uncontrolled hypertension
- Active uncontrolled infections or immunodeficiency including HIV or organ transplantation history
- Active chronic hepatitis B or C (with some exceptions for stable or cured cases)
- Prior immunotherapy with serious immune-related side effects
- Known allergy to study treatment components
- Pregnant or lactating women, or unwillingness to use contraception during and for 6 months after treatment
- Severe other diseases or conditions interfering with treatment or judged unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
2
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
Z
Zhijun Dai, Professor
CONTACT
Y
Youyi Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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