RecruitingPhase 2NCT06611813

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)

Neoadjuvant Chemotherapy Combined With Toripalimab for HR+/HER2- Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST01)


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

30 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response(PCR)and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called toripalimab to standard chemotherapy before surgery improves outcomes for women with a specific type of breast cancer that is hormone receptor-positive (HR+) and HER2-negative. This approach — giving treatment before surgery to shrink the tumor — is called neoadjuvant therapy. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with invasive HR+/HER2- breast cancer with a tumor larger than 1 cm - Your cancer has not spread to distant parts of the body - You are in generally good physical health (ECOG score 0–1) **You may NOT be eligible if...** - You have already received chemotherapy or hormone therapy for this cancer - You have a serious autoimmune condition or are on immune-suppressing medications - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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 Toripalimab

Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant and postoperative adjuvant therapy for a total of 1 year.

DRUGHR+ HER2 breast cancer

During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant therapy and postoperative adjuvant therapy for a total of 1 year.


Locations(11)

The First Affiliated Hospital of Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Jinhua Municipal Central Hospital

Jinhua, China

Nanchang People's Hospital

Nanchang, China

Zhongshan Hospital, Fudan University

Shanghai, China

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, China

Shaanxi Provincial Cancer Hospital

Xi'an, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06611813


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