Actively Recruiting
The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2024-11-19
42
Participants Needed
16
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent/metastatic breast cancer.
CONDITIONS
Official Title
The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily agree to join and sign informed consent.
- Age between 18 and 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival longer than 3 months.
- Diagnosed with HER2 negative breast cancer with local recurrence or distant metastasis, not suitable for curative surgery or radiation.
- Availability of sufficient tumor tissue for HER2 evaluation.
- Prior treatment failure after at least first-line systemic chemotherapy during recurrence/metastasis; for hormone receptor positive, failure after CDK4/6 inhibitors combined with endocrine therapy.
- Disease progression or intolerance during or after the most recent treatment.
- At least one measurable lesion per RECIST 1.1 criteria.
- Adequate organ function meeting study standards.
- Female participants of childbearing potential must use contraception during and 6 months post-study; negative pregnancy test within 7 days before enrollment; non-lactating.
- Male participants must agree to use contraception during and 6 months post-study.
You will not qualify if you...
- History or current other malignant tumors within 5 years before first study drug dose.
- Uncontrollable toxic reactions above CTCAE grade 1 from previous treatments.
- Significant surgery or trauma within 28 days before first drug dose.
- Unhealed wounds or fractures.
- History or evidence of interstitial lung disease or pneumonia requiring steroids or suspected on screening imaging.
- Arterial or venous thrombotic event within 6 months before first drug dose.
- History of psychiatric drug abuse or mental disorders preventing quitting.
- Severe or uncontrolled diseases including Grade IV rheumatoid arthritis requiring wheelchair or bed rest.
- Anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy) within 4 weeks before first drug dose or within 5 half-lives of prior drug.
- Endocrine or traditional Chinese patent medicines with anti-tumor indication within 2 weeks before first drug dose.
- Tumor invading major blood vessels or likely to cause fatal bleeding.
- Uncontrollable pleural effusion, ascites, or moderate to severe pericardial effusion needing repeated drainage.
- Known cancerous meningitis or active central nervous system metastasis.
- Severe bone damage from tumor metastasis or lung diseases unsuitable for study participation.
- Allergy to investigational drug, excipients, or humanized monoclonal antibodies.
- Participation in other anti-tumor drug trials within 4 weeks before first drug dose.
- Any condition judged by investigators 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: 16 locations
1
Bozhou People's Hospital
Bozhou, Anhui, China, 236804
Not Yet Recruiting
2
Chuzhou First People's Hospital
Chuzhou, Anhui, China, 239001
Not Yet Recruiting
3
Anhui Provincial Public Health Clinical Center
Hefei, Anhui, China, 230031
Not Yet Recruiting
4
Ma'anshan People's Hospital
Ma’anshan, Anhui, China, 243000
Not Yet Recruiting
5
Wuhu Hospital Affiliated to East China Normal University
Wuhu, Anhui, China, 241399
Not Yet Recruiting
6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
7
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
8
The First People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450003
Actively Recruiting
9
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Not Yet Recruiting
10
The First People's Hospital of Changde City
Changde, Hunan, China, 415003
Not Yet Recruiting
11
Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
12
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
13
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
Not Yet Recruiting
14
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
15
Suzhou Municipal Hospital
Suzhou, Zhejiang, China, 234099
Not Yet Recruiting
16
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China, 325015
Not Yet Recruiting
Research Team
K
Kunwei Shen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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