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

Prior treatment

• Combined diseases and medical history
  • Have had or currently have other malignant tumors within the past 5 years of randomization
  • Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
  • Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
  • There are diseases that affect intravenous injection and venous blood collection
  • There are congenital bleeding and coagulation disorders present
  • An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
  • Poor blood pressure control
  • Suffering from significant cardiovascular disease
  • There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
  • History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
  • Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
  • Active viral hepatitis with poor control
  • Active syphilis infected individuals in need of treatment
  • Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
  • Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
  • History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
  • Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0 g
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis
  • Poor control of diabetes
  • Individuals with epilepsy who require treatment
  • Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
• Tumor related symptoms and treatment
  • There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods
  • History of cumulative dose exposure to anthracyclines in the past
  • 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
  • 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
  • Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;
  • Allergic to any research drug or any ingredient or excipient in the drug;
  • Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;
  • Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.

Other

• 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
• 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.

• 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