Clinical trial NCT07003074: A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 642
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

  1. Have had or currently have other malignant tumors within the past 5 years of randomization
  2. Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
  3. Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
  4. There are diseases that affect intravenous injection and venous blood collection
  5. There are congenital bleeding and coagulation disorders present
  6. An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
  7. Poor blood pressure control
  8. Suffering from significant cardiovascular disease
  9. There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
  10. History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
  11. Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
  12. Active viral hepatitis with poor control
  13. Active syphilis infected individuals in need of treatment
  14. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
  15. Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
  16. History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
  17. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0 g
  18. Patients with renal failure requiring hemodialysis or peritoneal dialysis
  19. Poor control of diabetes
  20. Individuals with epilepsy who require treatment
  21. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
* Tumor related symptoms and treatment

  1. There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods
  2. History of cumulative dose exposure to anthracyclines in the past
  3. Received radiation therapy within 3 weeks prior to the start of study treatment and endocrine therapy within 2 weeks prior to the start of study treatment
  4. Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment
* Research treatment related

  1. Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;
  2. Allergic to any research drug or any ingredient or excipient in the drug;
  3. Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;
  4. Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.
* According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to approximately 30 months
measure: Progression-Free Survival
timeFrame: Up to approximately 30 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 30 months
measure: Duration of Remission
timeFrame: Up to approximately 30 months
measure: The incidence of adverse events
timeFrame: Up to approximately 52 months
measure: The severity of adverse events
timeFrame: Up to approximately 52 months
measure: Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102
timeFrame: 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)
measure: The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)
timeFrame: within 60 minutes prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8, Cycle16,and before administration and 28 days (± 7 days), (21 days as a treatment cycle)
measure: Total antibodies
timeFrame: 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)
measure: The small molecule toxin TQ22723
timeFrame: 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)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tiantan Hospital,Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
city: Harbin
country: China
facility: Affiliated Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Third People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital Of Dalian University
state: Liaoning
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital Of Dalian University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Provincial Cancer Hospital
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'An Jiaoting Yniversity
state: Shaanxi
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Fudan University shanghai cancer center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital, Shanxi Province
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: