Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2025-06-23
Last updated
2025-06-25
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
TQB2102 for InjectionDocetaxel combined + Trastuzumab +Pertuzumab
TQB2102 for Injection: TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate — Up to approximately 30 months According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Progression-Free Survival — Up to approximately 30 months It refers to the time between enrollment and the occurrence of objective disease progression or death caused by various reasons (whichever occurs first).
Trial sites (25)
Facility
City
Region
Status
Anhui Provincial Cancer Hospital
Hefei
Anhui
Not Yet Recruiting
Anhui Provincial Hospital
Hefei
Anhui
Not Yet Recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing
Beijing Municipality
Not Yet Recruiting
Gansu Provincial Cancer Hospital
Lanzhou
Gansu
Not Yet Recruiting
Gansu Provincial Cancer Hospital
Lanzhou
Gansu
Not Yet Recruiting
Shantou Central Hospital
Shantou
Guangdong
Not Yet Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin
Heilongjiang
Not Yet Recruiting
Huaihe Hospital of Henan University
Kaifeng
Henan
Not Yet Recruiting
Puyang Oilfield General Hospital
Puyang
Henan
Not Yet Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou
Henan
Not Yet Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Hubei
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
Jiangsu Provincial People's Hospital
Nanjing
Jiangsu
Not Yet Recruiting
The first hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
Affiliated Zhongshan Hospital Of Dalian University
Dalian
Liaoning
Not Yet Recruiting
Affiliated Zhongshan Hospital Of Dalian University
Dalian
Liaoning
Not Yet Recruiting
Liaoning Provincial Cancer Hospital
Shenyang
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Xi'An Jiaoting Yniversity
Xi'an
Shaanxi
Not Yet Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Not Yet Recruiting
Fudan University shanghai cancer center
Shanghai
Shanghai Municipality
Not Yet Recruiting
Shanxi Cancer Hospital
Taiyuan
Shanxi
Not Yet Recruiting
Yuncheng Central Hospital, Shanxi Province
Yuncheng
Shanxi
Not Yet Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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