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

Overview

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.

Interventions

• Drug TQB2102 Injection
  TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.
• Drug Trastuzumab Emtansine for Injection
  Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).

Primary outcome measures

• The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC) [Time frame: Up 30 months]

Secondary outcome measures (11)

• The PFS evaluated by the researchers [Time frame: Up 30 months]
• The Overall Survival (OS) evaluated by the researchers [Time frame: Up to 5 years]
• The Duration of Response (DOR) evaluated by the researchers [Time frame: Up to 5 years]
• The Partial Response (PR) evaluated by the researchers [Time frame: Up to 5 years]
• The Objective Response Rate (ORR)evaluated by the researchers [Time frame: Up to 5 years]
• The Clinical Benefit Rate (CBR) evaluated by the researchers [Time frame: Up to 5 years]
• The incidence and severity of adverse events [Time frame: 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))]
• Antibody-drug conjugate (ADC) [Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)]
• Total antibodies [Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)]
• The small molecule toxin TO22723 [Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)]
• The incidence rate of Anti-Drug Antibody (ADA) [Time frame: Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks)]

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.

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 · 31 centers

• The First Affiliated Hospital of Anhui Medical University — Bengbu
• Anhui Provincial Cancer Hospital — Hefei
• The First Affiliated Hospital of Anhui Medical University — Hefei
• Peking University First Hospital — Beijing
• Beijing Shunyi Hospital — Beijing
• Fujian Cancer Hospital — Fuzhou
• The First Hospital Of Lanzhou University — Lanzhou
• Jiangmen Central Hospital — Jiangmen
• … and 23 more centers

Identifiers

NCT: NCT07008976 · TQB2102-III-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗