Status:
ACTIVE_NOT_RECRUITING
A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.
Eligibility Criteria
Inclusion
- Voluntarily participate in this study and sign informed consent;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected survival of more than 3 months;
- Histologically confirmed invasive breast cancer, no history of any systemic anti-tumor therapy for breast cancer;
- Confirmed as HER2 positive;
- Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
- Agree to undergo breast cancer surgery when reaching the surgical criteria after neoadjuvant therapy;
- Major organ functions are good, meeting certain criteria;
- Agree to use contraception during the study and within 6 months after the study ends; female patients must have a negative serum pregnancy test within 7 days before enrollment and must be non-lactating.
Exclusion
- IV stage metastatic breast cancer or deemed unable to achieve curative surgical resection through neoadjuvant therapy by other investigators.
- Bilateral invasive breast cancer.
- Coexisting diseases and medical history:
- History of invasive breast cancer.
- Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
- Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
- Unhealed wounds or fractures.
- Ocular diseases deemed clinically significant by the investigator.
- Occurrence of arterial/deep venous thrombotic events within the last 6 months.
- History of substance abuse with inability to quit or individuals with mental disorders.
- ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
- Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
- History of interstitial lung disease/pneumonia requiring intervention with steroid treatment, or current presence, or suspected interstitial lung disease/pneumonia during the screening period that cannot be ruled out by the investigator; individuals with pulmonary diseases deemed unsuitable for participation by the investigator.
- Tumor-related symptoms and treatment:
- Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
- Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
- Radiological evidence of tumor invasion into major vessels or judged by the investigator to be highly likely to invade major vessels during the subsequent study period, leading to fatal hemorrhage.
- Study treatment-related:
- Experienced severe hypersensitivity reactions after using monoclonal antibodies.
- Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
- Allergic to any component or excipient in any study drug.
- Participated in other clinical trials of anti-tumor drugs within 4 weeks before the start of the study.
- Deemed inappropriate for inclusion based on the investigator's judgment.
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06198751
Start Date
February 5 2024
End Date
February 1 2028
Last Update
August 19 2025
Active Locations (7)
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1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
3
Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550001
4
Harbin medical university cancer hospital
Harbin, Heilongjiang, China, 150040