Actively Recruiting
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-06-25
642
Participants Needed
25
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily enrolled in this study with good compliance
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
- Defined hormone receptor (HR) status
- No systemic anti-tumor therapy received during recurrence/metastasis stage, except first-line endocrine therapy
- If receiving new adjuvant therapy, at least 12 months between end of systemic therapy (excluding endocrine therapy) and recurrence/metastasis
- At least one measurable lesion according to RECIST 1.1 criteria
- Good major organ function
You will not qualify if you...
- Known spinal cord compression or active central nervous system metastasis
- Only skin and/or brain lesions as target lesions
- Other malignant tumors within the past 5 years
- Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 from previous treatment
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
- Diseases affecting intravenous injection and venous blood collection
- Congenital bleeding and coagulation disorders
- Arterial or deep vein thrombosis event within 6 months before first administration
- Poor blood pressure control
- Significant cardiovascular disease
- Uncontrolled infection of CTC AE grade 2 or higher within 14 days before treatment
- History of interstitial lung disease or pneumonia requiring steroids
- Moderate to severe pulmonary dysfunction within 3 months prior to first administration
- Active viral hepatitis with poor control
- Active syphilis needing treatment
- Preparation for or history of allogeneic bone marrow or solid organ transplantation
- Need for immunosuppressants or systemic/absorbable local hormone therapy causing immunosuppression
- History of immunodeficiency including HIV or congenital immunodeficiency
- Urinary protein ≥++ and 24-hour urinary protein >1.0 g
- Renal failure requiring dialysis
- Poorly controlled diabetes
- Epilepsy requiring treatment
- History of psychotropic drug abuse or mental disorders unable to quit
- Uncontrollable third interstitial fluid accumulation or cancerous lymphangitis
- Prior cumulative anthracycline exposure
- Radiation therapy within 3 weeks or endocrine therapy within 2 weeks prior to study treatment
- Use of traditional Chinese patent medicines with anti-tumor indications within 2 weeks prior to treatment
- Previous antibody conjugate therapy with topoisomerase I inhibitors
- Allergy to any study drug or excipients
- Severe hypersensitivity to monoclonal antibodies
- Participation in other anti-tumor clinical trials within 4 weeks before study treatment
- Any condition judged by the researcher to seriously endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
3
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
4
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
5
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
6
Shantou Central Hospital
Shantou, Guangdong, China, 515031
Not Yet Recruiting
7
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
8
Huaihe Hospital of Henan University
Kaifeng, Henan, China, 475099
Not Yet Recruiting
9
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001
Not Yet Recruiting
10
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
11
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 434000
Not Yet Recruiting
12
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
13
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
14
The first hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
15
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, China, 116000
Not Yet Recruiting
16
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, China, 116000
Not Yet Recruiting
17
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
18
The First Affiliated Hospital of Xi'An Jiaoting Yniversity
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
19
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
20
Fudan University shanghai cancer center
Shanghai, Shanghai Municipality, China, 201321
Not Yet Recruiting
21
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
22
Yuncheng Central Hospital, Shanxi Province
Yuncheng, Shanxi, China, 044099
Not Yet Recruiting
23
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
24
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
25
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 831399
Not Yet Recruiting
Research Team
Z
Zhimin Shao, Doctor
CONTACT
Y
Yongmei Yin, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here