RecruitingPhase 2NCT06874933

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

35 participants

Start Date

May 4, 2025

Study Type

INTERVENTIONAL

Conditions

HR+/HER2- Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy with two new drugs — anlotinib (an anti-tumor blood vessel drug) and benmelstobart (an immunotherapy drug) — given before surgery for a specific type of breast cancer. **You may be eligible if...** - You are a woman aged 18 to 75 - You are in reasonably good general health (ECOG 0-1) - You have been diagnosed with hormone receptor-positive (ER+), HER2-negative invasive breast cancer - Your tumor is at least 1 cm in size and meets specific staging criteria - Your tumor has a high immune activity score (CPS greater than a set threshold) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have received prior chemotherapy or targeted therapy for this cancer - You have severe heart, liver, or kidney problems - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant 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.