NCT06874933

Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)

A Prospective, Single-Arm Clinical Study on the Treatment of HR+/HER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HR+/HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-05-04
• Primary completion: 2027-04-01
• Completion: 2030-04-01
• First posted: 2025-03-13
• Last updated: 2025-08-12

Locations

3 sites across 1 country: China