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

Overview

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.

Interventions

• Drug TQB2102 for Injection
  TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.
• Drug Docetaxel combined + Trastuzumab +Pertuzumab
  Positive control.

Primary outcome measures

• Objective Response Rate [Time frame: Up to approximately 30 months]
• Progression-Free Survival [Time frame: Up to approximately 30 months]

Secondary outcome measures (8)

• Overall Survival [Time frame: Up to approximately 30 months]
• Duration of Remission [Time frame: Up to approximately 30 months]
• The incidence of adverse events [Time frame: Up to approximately 52 months]
• The severity of adverse events [Time frame: Up to approximately 52 months]
• Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102 [Time frame: 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)]
• The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb) [Time frame: 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)]
• Total antibodies [Time frame: 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)]
• The small molecule toxin TQ22723 [Time frame: 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)]

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

• 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
• Active syphilis infected individuals in need of treatment
• Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
• Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
• History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
• Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g
• Patients with renal failure requiring hemodialysis or peritoneal dialysis
• Poor control of diabetes
• Individuals with epilepsy who require treatment
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
• Tumor related symptoms and treatment

• There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods
• History of cumulative dose exposure to anthracyclines in the past
• 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
• 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

• Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;
• Allergic to any research drug or any ingredient or excipient in the drug;
• Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 25 centers

• Anhui Provincial Cancer Hospital — Hefei
• Anhui Provincial Hospital — Hefei
• Beijing Tiantan Hospital,Capital Medical University — Beijing
• Gansu Provincial Cancer Hospital — Lanzhou
• Gansu Provincial Cancer Hospital — Lanzhou
• Shantou Central Hospital — Shantou
• Affiliated Cancer Hospital of Harbin Medical University — Harbin
• Huaihe Hospital of Henan University — Kaifeng
• … and 17 more centers

Identifiers

NCT: NCT07003074 · TQB2102-III-06

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗