Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
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
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)
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku 18-75 lat
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (skala ECOG 0-1)
- •Potwierdzony histopatologicznie rak piersi z guzem większym niż 1 cm, dodatnim na hormony (HR+) i ujemnym na receptor HER2
- •Prawidłowe wyniki morfologii krwi: liczba neutrofili >1,5, płytki >75, hemoglobina >90
- •Prawidłowe wyniki biochemii krwi: bilirubina, enzymy wątrobowe i funkcja nerek w normie
- •Frakcja wyrzutowa lewej komory serca >55% (badanie echokardiograficzne)
- •Odstęp QT w EKG <470 ms
- •Świadoma zgoda na udział w badaniu i gotowość do współpracy
✗ Disqualifies
- •Rak piersi w stadium IV (zaawansowany)
- •Zapalny rak piersi
- •Wcześniejsze leczenie przeciwnowotworowe lub radioterapia (z wyjątkiem wyzdrowień z nowotworu, np. raka szyjki macicy in situ)
- •Jednoczesne uczestnictwo w innych badaniach klinicznych z lekami przeciwnowotworowymi
- •Poważne zabiegi chirurgiczne niezwiązane z rakiem piersi w ostatnim czasie
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 12, 2025
- Sex
- Female only
Therapies / drugs in trial
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
Trial contact
Zhijun Dai
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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