Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
Recruiting · NCT07008976 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
TQB2102 InjectionTrastuzumab Emtansine for Injection
What this trial is about
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months;
- HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination;
- According to the 2018 version of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive;
- The hormone receptor (HR) status has been clearly determined:
- a) According to the 2020 version of the ASCO/CAP guidelines, HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%.
- Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage.
- Disease progression occurred during or after the most recent treatment or intolerance.
- At least 1 line of treatment has been received in the recurrence/metastasis stage.
- According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, at least one measurable lesion exists.
Exclusion criteria
- Excluded are patients with known spinal cord compression or active central nervous system metastases .
- Patients with only skin and/or intracranial lesions as target lesions.
- Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1.
- Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- Patients with major cardiovascular diseases
- Patients with a history of interstitial lung disease/pneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening period imaging and cannot be excluded.
Where it is running
31 locations listed.
- The First Affiliated Hospital of Anhui Medical University - Bengbu, Anhui, China
- Anhui Provincial Cancer Hospital - Hefei, Anhui, China
- The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- Peking University First Hospital - Beijing, Beijing Municipality, China
- Beijing Shunyi Hospital - Beijing, Beijing Municipality, China
- Fujian Cancer Hospital - Fuzhou, Fujian, China
- The First Hospital Of Lanzhou University - Lanzhou, Gansu, China
- Jiangmen Central Hospital - Jiangmen, Guangdong, China
- Affiliated Cancer Hospital Of Guangxi Medical University - Nanning, Guangxi, China
- Cancer Hospital Of Guizhou Medical University - Guiyang, Guizhou, China
- Hainan General Hospital - Haikou, Hainan, China
- The Fourth Hospital Of Hebei Medical University - Shijiazhuang, Hebei, China
- Affiliated Cancer Hospital Of Harbin Medical University - Harbin, Heilongjiang, China
- Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital) - Jiamusi, Heilongjiang, China
- Anyang Cancer Hospital - Anyang, Henan, China
- The First Affiliated Hospital Of Henan University Of Science & Technology - Luoyang, Henan, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- Chifeng Municipal Hospital - Chifeng, Inner Mongolia, China
- Jiangxi Cancer Hospital - Nanchang, Jiangxi, China
- Jilin Cancer Hospital - Changchun, Jilin, China
- The First Hospital of Jilin University - Changchun, Jilin, China
- The Second Hospital Of Dalian Medical University - Dalian, Liaoning, China
- Liaoning Cancer Hospital & Institute - Shenyang, Liaoning, China
- Affiliated Hospital Of Jining Medical University - Jining, Shandong, China
- Linyi Cancer Hospital - Linyi, Shandong, China
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China
- Dazhopu Central Hospital - Dazhou, Sichuan, China
- Affiliated Hospital of North Sichuan Medical College - Nanchong, Sichuan, China
- Tianjin Medical University Cancer Institute & Hospital - Tianjin, Tianjin Municipality, China
- Hangzhou Cancer Hospital - Hangzhou, Zhejiang, China