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

Recruiting now · Phase 3

Conditions studied: HER2-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT07043725

Run by

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

People needed

544

Starts

2025-09-15

Expected to finish

2029-09-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily participate in this study, sign the informed consent form, and have good compliance;
• Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival >6 months;
• Histologically or cytologically confirmed HER2-positive invasive breast cancer;
• Hormone receptor (HR) status confirmed;
• Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0;
• Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy;
• Major organ function is adequate, meeting specific criteria;
• Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion

You may not qualify if…

• Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
• Bilateral breast cancer or inflammatory breast cancer;
• History of invasive breast cancer or ductal carcinoma in situ;
• Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;
• Comorbidities and medical history:
• Other malignancies within 5 years or currently;
• Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1;
• Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures;
• Conditions affecting intravenous injection or blood sampling;
• Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin >325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment;
• Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism;
• Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
• Significant cardiovascular disease, including；
• Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment;
• History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out;
• Tumor-related symptoms and treatment:
• Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment;
• Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment);
• Prior taxane or carboplatin therapy for any malignancy;
• Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment.
• Study treatment-related:
• Severe hypersensitivity to monoclonal antibodies;
• Uncontrolled active autoimmune disease within 2 weeks before study treatment;
• Allergy to any study drug or its components/excipients;
• Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• Jiamusi Cancer Hospital — Jiamusi, Heilongjiang, China (enrolling)
• The First Affiliated Hospital of Wannan Medical University — Wuhu, Anhui, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• The First Hospital Affiliated to Army Medical University — Chongqing, Chongqing Municipality, China
• Quanzhou First Hospital — Quanzhou, Fujian, China
• The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China
• Zhongshan Hospital Xiamen university — Xiamen, Fujian, China
• ZhangZhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China
• Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• Gansu Wuwei Tumour Hospital — Wuwei, Gansu, China
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• Meizhou People's Hospital — Meizhou, Guangdong, China
• Shantou Central Hospital — Shantou, Guangdong, China
• Guigang City People's Hospital — Guigang, Guangxi, China
• Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center) — Nanning, Guangxi, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• The Affiliated Cancer Hospital of Guizhou Medical University — Guiyang, Guizhou, China
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China
• The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center — Chongqing, Chongqing Municipality, China

Full record on ClinicalTrials.gov

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