Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer
1 other identifier
interventional
246
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Typical duration for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2025
CompletedFirst Posted
Study publicly available on registry
June 6, 2025
CompletedStudy Start
First participant enrolled
July 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
August 14, 2025
April 1, 2025
2.7 years
May 30, 2025
August 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
The PFS evaluation of TQB2102 for injection compared with Trastuzumab Emtansine for injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the Independent Imaging Review Committee (IRC).
Up 30 months
Secondary Outcomes (11)
The PFS evaluated by the researchers
Up 30 months
The Overall Survival (OS) evaluated by the researchers
Up to 5 years
The Duration of Response (DOR) evaluated by the researchers
Up to 5 years
The Partial Response (PR) evaluated by the researchers
Up to 5 years
The Objective Response Rate (ORR)evaluated by the researchers
Up to 5 years
- +6 more secondary outcomes
Study Arms (2)
TQB2102 Injection
EXPERIMENTALThe drug is administered by intravenous infusion, at a dose of 6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle.
Trastuzumab Emtansine for Injection
ACTIVE COMPARATORThe drug is administered by intravenous infusion, at a dose of 3.6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle.
Interventions
TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.
Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
The First Affiliated Hospital of Anhui Medical University
Bengbu, Anhui, 233099, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Shunyi Hospital
Beijing, Beijing Municipality, 101300, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
The First Hospital Of Lanzhou University
Lanzhou, Gansu, 730000, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Affiliated Cancer Hospital Of Guangxi Medical University
Nanning, Guangxi, 530028, China
Cancer Hospital Of Guizhou Medical University
Guiyang, Guizhou, 550001, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The Fourth Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050035, China
Affiliated Cancer Hospital Of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, 154007, China
Anyang Cancer Hospital
Anyang, Henan, 455001, China
The First Affiliated Hospital Of Henan University Of Science & Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Hospital Of Dalian Medical University
Dalian, Liaoning, 116000, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110041, China
Affiliated Hospital Of Jining Medical University
Jining, Shandong, 272029, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Dazhopu Central Hospital
Dazhou, Sichuan, 635000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2025
First Posted
June 6, 2025
Study Start
July 7, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
August 14, 2025
Record last verified: 2025-04