A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer

This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.

Inclusion Criteria:

• Subjects voluntarily enrolled in this study with good compliance
• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1
• HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
• Defined hormone receptor (HR) status
• Has not received systemic anti-tumor therapy during the recurrence/metastasis stage (acceptable ≤ first-line endocrine therapy)
• If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence/metastasis be greater than 12 months
• Have at least one measurable lesion according to RECIST 1.1 criteria;
• Good major organ function

Exclusion Criteria:

• It is known that there is spinal cord compression or active central nervous system metastasis;

• Subjects with only skin and/or brain lesions as target lesions

• Combined diseases and medical history

  1. Have had or currently have other malignant tumors within the past 5 years of randomization
  2. Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
  3. Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
  4. There are diseases that affect intravenous injection and venous blood collection
  5. There are congenital bleeding and coagulation disorders present
  6. An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
  7. Poor blood pressure control
  8. Suffering from significant cardiovascular disease
  9. There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
  10. History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
  11. Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
  12. Active viral hepatitis with poor control
  13. Active syphilis infected individuals in need of treatment
  14. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
  15. Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
  16. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
  17. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g
  18. Patients with renal failure requiring hemodialysis or peritoneal dialysis
  19. Poor control of diabetes
  20. Individuals with epilepsy who require treatment
  21. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders

• Tumor related symptoms and treatment

  1. There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods
  2. History of cumulative dose exposure to anthracyclines in the past
  3. Received radiation therapy within 3 weeks prior to the start of study treatment and endocrine therapy within 2 weeks prior to the start of study treatment
  4. Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment

• Research treatment related

  1. Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;
  2. Allergic to any research drug or any ingredient or excipient in the drug;
  3. Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;
  4. Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.

• According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.