Clinical trial NCT07008976: Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
timeFrame: Up 30 months
Secondary outcomes:
measure: The PFS evaluated by the researchers
timeFrame: Up 30 months
measure: The Overall Survival (OS) evaluated by the researchers
timeFrame: Up to 5 years
measure: The Duration of Response (DOR) evaluated by the researchers
timeFrame: Up to 5 years
measure: The Partial Response (PR) evaluated by the researchers
timeFrame: Up to 5 years
measure: The Objective Response Rate (ORR)evaluated by the researchers
timeFrame: Up to 5 years
measure: The Clinical Benefit Rate (CBR) evaluated by the researchers
timeFrame: Up to 5 years
measure: The incidence and severity of adverse events
timeFrame: Sign the informed consent form, and until 28 days after the last medication administration / before starting a new anti-tumor treatment (which ever occurs first))
measure: Antibody-drug conjugate (ADC)
timeFrame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
measure: Total antibodies
timeFrame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
measure: The small molecule toxin TO22723
timeFrame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)
measure: The incidence rate of Anti-Drug Antibody (ADA)
timeFrame: Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks)
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shunyi Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital Of Lanzhou University
state: Gansu
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital Of Guangxi Medical University
state: Guangxi
city: Guiyang
country: China
facility: Cancer Hospital Of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Fourth Hospital Of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Affiliated Cancer Hospital Of Harbin Medical University
state: Heilongjiang
city: Jiamusi
country: China
facility: Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital Of Henan University Of Science & Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Inner Mongolia
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital Of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Jining
country: China
facility: Affiliated Hospital Of Jining Medical University
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Dazhou
country: China
facility: Dazhopu Central Hospital
state: Sichuan
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
References: