RecruitingPhase IIIEN originalBreast cancerHER2 positive

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

⚠️

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 is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Zgoda na udział i stosowanie się do zaleceń lekarzy.
  • Ogólny stan zdrowia pozwalający na aktywne życie (wynik 0-1 w skali ECOG).
  • Rak piersi HER2-dodatni, potwierdzony badaniami.
  • Potwierdzony status receptorów hormonalnych (HR).
  • Wczesne stadia raka piersi (od T2 do T4 z różnymi N, ale bez przerzutów M0, lub dowolne T z N1-N3, bez przerzutów M0).
  • Zgoda na operację usunięcia raka po leczeniu przedoperacyjnym.
  • Sprawnie działające główne narządy wewnętrzne.
  • Konieczność stosowania antykoncepcji przez cały okres badania i 6 miesięcy po jego zakończeniu. Kobiety muszą mieć negatywny test ciążowy przed rozpoczęciem badania i nie mogą karmić piersią.

✗ Disqualifies

  • Rak piersi w stadium IV z przerzutami lub uznany przez lekarza za nienadający się do leczenia operacyjnego po terapii przedoperacyjnej.
  • Rak piersi w obu piersiach lub rak zapalny piersi.
  • Wcześniejsza historia raka piersi (inwazyjnego lub przewodowego in situ).
  • Wcześniejsze leczenie raka piersi (chemioterapia, hormonoterapia, leczenie celowane, radioterapia, operacja itp.).
  • Inne choroby nowotworowe w ciągu ostatnich 5 lat lub obecnie.
  • Poważne reakcje na poprzednie leczenie, które nie ustąpiły.
  • Poważna operacja lub uraz w ciągu 4 tygodni przed badaniem, lub planowana poważna operacja w trakcie badania.
  • Choroby krwi, skłonność do krwawień lub przyjmowanie leków rozrzedzających krew (np. aspiryny w dawce powyżej 325 mg/dzień) w ciągu 7 dni przed badaniem.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
March 27, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (78)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Anhui Provincial Cancer Hospital

Hefei, China

The First Affiliated Hospital of Wannan Medical University

Wuhu, China

Peking Union Medical College Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center

Chongqing, China

The First Hospital Affiliated to Army Medical University

Chongqing, China

Quanzhou First Hospital

Quanzhou, China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, China

Zhongshan Hospital Xiamen university

Xiamen, China

ZhangZhou Municipal Hospital of Fujian Province

Zhangzhou, China

The First Hospital of Lanzhou University

Lanzhou, China

Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital

Lanzhou, China

Gansu Wuwei Tumour Hospital

Wuwei, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Meizhou People's Hospital

Meizhou, China

Shantou Central Hospital

Shantou, China

Guigang City People's Hospital

Guigang, China

Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)

Nanning, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, China

Guizhou Provincial People's Hospital

Guiyang, China

Cangzhou Central Hospital

Cangzhou, China

First Hospital of QinHuangDao

Qinhuangdao, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Jiamusi Cancer Hospital

Jiamusi, China

Harbin Medical University Cancer Hospital

Harbin, China

Anyang Tumor Hospital

Anyang, China

The People's Hospital of Anyang City

Anyang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Zhongnan Hospital of Wuhan University

Wuhan, China

The Second Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital Central South University

Changsha, China

The First Affiliated Hospital of University of South China

Hengyang, China

Xiangya Hospital ZhuZhou Central South University

Zhuzhou, China

Chifeng Municipal Hospital

Chifeng, China

Jiangsu Province Hospital

Nanjing, China

Nanjing Drum Tower Hospital

Nanjing, China

NanChang People's Hospital

Nanchang, China

Jiangxi Cancer Hospital

Nanchang, China

The First Bethune Hospital of Jilin University

Changchun, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, China

Shengjing Hospital Of China Medical University

Shenyang, China

The First Affiliated Hospital of China Medical University

Shenyang, China

Liaoning Cancer Hospital & Institute

Shenyang, China

The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army

Xi'an, China

The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army

Xi'an, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital

Jinan, China

Linyi Cancer Hospital

Linyi, China

The Second Affiliated Hospital of Shandong First Medical University

Taian, China

WeiFang People's Hospital

Weifang, China

Weihai Municipal Hospital

Weihai, China

Yantai Yuhuangding Hospital

Yantai, China

Zibo Central Hospital

Zibo, China

Fudan University Shanghai Cancer Center

Shanghai, China

Huashan Hospital Fudan University

Shanghai, China

Shanxi Cancer Hospital

Taiyuan, China

First Hospital of Shanxi Medical University

Taiyuan, China

Yuncheng Central Hospital

Yuncheng, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, China

The Affiliated Hospital of Southwest Medical University

Luzhou, China

The Second People's Hospital of YiBin

Yibin, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Xinjiang Medical University Cancer Hospital

Ürümqi, China

Xinjiang Medical University Cancer Hospital

Ürümqi, China

Ningbo Medical Center Lihuili Hospital

Ningbo, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Shaoxing People's Hospital

Shaoxing, China

Taizhou Hospital of Zhejiang Province

Taizhou, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Trial contact

Zhimin Shao, Doctor

Caigang Liu, Doctor

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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