Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18-75 lat
- •Dobry stan ogólny (zdolna do codziennych aktywności)
- •Potwierdzony histopatologicznie rak piersi bez przerzutów, guz większy niż 1 cm, hormonowrażliwy, bez nadekspresji receptora HER2
- •Prawidłowe wyniki badań krwi: odpowiednia liczba neutrofili, płytek i hemoglobiny
- •Prawidłowe wyniki badań wątroby i nerek
- •Prawidłowa funkcja serca (frakcja wyrzutowa ponad 55%)
- •Prawidłowy zapis EKG (QT poniżej 470 ms)
- •Stosowanie skutecznej antykoncepcji przez co najmniej 6 miesięcy po końcu badania (dla kobiet w wieku rozrodczym)
✗ Disqualifies
- •Rak piersi w stadium IV (przerzuty odległe)
- •Zapalny rak piersi
- •Poprzednia chemioterapia lub radioterapia z powodu nowotworu
- •Jednoczesne uczestnictwo w innych badaniach klinicznych z lekami przeciwnowotworowymi
- •Niedawna poważna operacja chirurgiczna niezwiązana z rakiem piersi
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- May 18, 2025
- Sex
- Female only
Therapies / drugs in trial
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
Trial contact
Zhijun Dai, Professor
Youyi Chen
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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