RecruitingPhase 3NCT06977893

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

194 participants

Start Date

Mar 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy 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 whether adding an immunotherapy drug called toripalimab (a PD-1 blocker) to standard chemotherapy before surgery helps shrink tumors in women with a hormone-receptor positive, HER2-negative breast cancer that also shows signs of immune activity (PD-L1 positive). **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with HR+/HER2- invasive breast cancer with a tumor larger than 1 cm - Your cancer tests positive for PD-L1 - You have not yet received chemotherapy - Your overall health and organ function are within acceptable ranges - Your heart's pumping function is greater than 55% **You may NOT be eligible if...** - You have another active cancer - You have significant heart, liver, or kidney problems - You are pregnant or planning to become pregnant - You have autoimmune disease or a history of serious immune-related side effects 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.

DRUGNeoadjuvant Chemotherapy

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.


Locations(13)

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

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

Nantong First People's Hospital

Nantong, China

Zhongshan Hospitall, 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

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NCT06977893


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