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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TQB2102 for people with HER2-positive breast cancer, a type of breast cancer that grows quickly and needs specific targeted therapy. The study aims to see if TQB2102 works as well and is as safe as the current standard treatment before surgery, helping to shrink the tumor and improve outcomes. Researchers will look at how well the cancer responds to the treatment, how long patients stay free from cancer, overall survival, and any side effects.

The trial is open to adults with confirmed HER2-positive breast cancer who have not yet had cancer treatment and are healthy enough to participate. Participants need to agree to follow the study plan, including having surgery after the treatment if it’s recommended. Both men and women can join, but women must not be pregnant or breastfeeding and need to use birth control during and for six months after the study. Participants will receive the study treatment before surgery and will be closely monitored for effectiveness and any side effects. This study is not recruiting yet, but it will take place at multiple centers to help find better options for treating this type of breast cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.
• • Any condition judged by the investigator to jeopardize subject safety or study completion.