Metastatic Breast Cancer
Conditions
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.
Interventions
TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.
Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC) | Up 30 months | The PFS evaluation of TQB2102 for injection compared with Trastuzumab Emtansine for injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the Independent Imaging Review Committee (IRC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Overall Survival (OS) evaluated by the researchers | Up to 5 years | The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine, as evaluated by the researchers, in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs. |
| The Duration of Response (DOR) evaluated by the researchers | Up to 5 years | The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine as evaluated by the researchers in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was studied. |
| The Partial Response (PR) evaluated by the researchers | Up to 5 years | The efficacy of PR-assessed TQB2102 injection compared with Trastuzumab Emtansine injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was evaluated by the researchers. |
| The Objective Response Rate (ORR)evaluated by the researchers | Up to 5 years | The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the objective response rate (ORR) was assessed in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs. |
| The Clinical Benefit Rate (CBR) evaluated by the researchers | Up to 5 years | The efficacy of CBR evaluated injection TQB2102 compared to injection Trastuzumab Emtansine in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers. |
| The PFS evaluated by the researchers | Up 30 months | The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the progression-free survival (PFS) in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers. |
| Antibody-drug conjugate (ADC) | Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks) | Evaluate the population pharmacokinetic (PK) characteristics of TOB2102 for injection in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs. |
| Total antibodies | Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks) | Evaluate the population pharmacokinetic (PK) characteristics of TOB2102 for injection in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs. |
| The small molecule toxin TO22723 | Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks) | The blood concentration of the small molecule toxin TO22723 in TOB2102. |
| The incidence rate of Anti-Drug Antibody (ADA) | Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks) | Evaluate the immunogenicity of injectable TQB2102 in conditions such as ADA incidence rate. Subjects with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs. |
| The incidence and severity of adverse events | 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)) | The proportion of patients experiencing adverse events, and these adverse events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Countries
China
Contacts
Primary ContactZhimin Shao, Doctor
Backup ContactJin Zhang, Doctor
Outcome results
None listed