A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer
1 other identifier
interventional
642
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jun 2025
25 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 21, 2025
CompletedFirst Posted
Study publicly available on registry
June 4, 2025
CompletedStudy Start
First participant enrolled
June 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
June 25, 2025
April 1, 2025
4 years
May 21, 2025
June 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate
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.
Up to approximately 30 months
Progression-Free Survival
It refers to the time between enrollment and the occurrence of objective disease progression or death caused by various reasons (whichever occurs first).
Up to approximately 30 months
Secondary Outcomes (8)
Overall Survival
Up to approximately 30 months
Duration of Remission
Up to approximately 30 months
The incidence of adverse events
Up to approximately 52 months
The severity of adverse events
Up to approximately 52 months
Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102
Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
- +3 more secondary outcomes
Study Arms (2)
TQB2102 for Injection
EXPERIMENTALAdminister by intravenous infusion, with a 21-day treatment cycle.
Docetaxel combined + Trastuzumab +Pertuzumab
ACTIVE COMPARATORDocetaxel: 75mg/m2, administered once every 3 weeks, intravenous infusion for 60 minutes, for a total of 6 cycles; Trastuzumab: The initial loading dose is 8mg/kg, and 6mg/kg is administered every 3 weeks thereafter; Pertuzumab: initial loading dose of 840mg, intravenous infusion for 60 minutes; Afterwards, administer 420mg every 3 weeks. After each infusion of pertuzumab, it is recommended to observe for 30-60 minutes. After the observation, trastuzumab or chemotherapy can be continued.
Interventions
TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.
Positive control.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Have had or currently have other malignant tumors within the past 5 years of randomization
- Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
- Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
- There are diseases that affect intravenous injection and venous blood collection
- There are congenital bleeding and coagulation disorders present
- An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
- Poor blood pressure control
- Suffering from significant cardiovascular disease
- There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
- History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
- Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
- Active viral hepatitis with poor control
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Shantou Central Hospital
Shantou, Guangdong, 515031, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 475099, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 434000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116000, China
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116000, China
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, 110000, China
The First Affiliated Hospital of Xi'An Jiaoting Yniversity
Xi'an, Shaanxi, 710000, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Fudan University shanghai cancer center
Shanghai, Shanghai Municipality, 201321, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
Yuncheng Central Hospital, Shanxi Province
Yuncheng, Shanxi, 044099, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 831399, 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 21, 2025
First Posted
June 4, 2025
Study Start
June 23, 2025
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2030
Last Updated
June 25, 2025
Record last verified: 2025-04