Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TQB2102 for patients with advanced breast cancer that tests positive for a protein called HER2. This type of breast cancer can be more aggressive, and the trial aims to compare TQB2102 to a standard treatment known as trastuzumab emtansine. Participants will be randomly assigned to receive one of these treatments to see which one helps extend the time before the cancer worsens.

To be eligible for the trial, participants must be between 18 and 75 years old and have a specific type of breast cancer that has not responded to prior treatments. They should also be in relatively good health, with a decent chance of living for more than three months. Patients with certain serious health issues, like uncontrolled high blood pressure or significant heart problems, cannot participate. This trial is not yet recruiting participants, but once it starts, those who join can expect close monitoring and support throughout their treatment.

Gender

ALL

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.