Status:
RECRUITING
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
- 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.
Key Trial Info
Start Date :
June 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
642 Patients enrolled
Trial Details
Trial ID
NCT07003074
Start Date
June 23 2025
End Date
July 1 2030
Last Update
June 25 2025
Active Locations (25)
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1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
3
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100050
4
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050