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Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
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.
Official title: A Prospective, Single-Arm Clinical Study on the Treatment of HR+/HER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-05-04
Completion Date
2030-04-01
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart
Group A: Epirubicin + cyclophosphamide + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by nab-paclitaxel + Benmelstobart administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is simultaneously combined. It is taken orally once a day, before breakfast. Take the medicine continuously for two weeks, then stop taking it for one week. One cycle is 21 days, and there are a total of 3 cycles. Group B: Nab-paclitaxel + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by Epirubicin + cyclophosphamide + Benmelstobart, which are administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is also used in combination. It should be taken orally once a day before breakfast, continuously for two weeks, then stop taking it for one week.
Locations (3)
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China