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NCT Number: NCT07008976

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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Anhui Medical University, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TQB2102 Injection

Drug

TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.

Trastuzumab Emtansine for Injection

Drug

Trastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).

Primary outcomes

  1. The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)

    Time frame: 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 outcomes

  1. The PFS evaluated by the researchers

    Time frame: 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.

  2. The Overall Survival (OS) evaluated by the researchers

    Time frame: 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.

  3. The Duration of Response (DOR) evaluated by the researchers

    Time frame: 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.

  4. The Partial Response (PR) evaluated by the researchers

    Time frame: 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.

  5. The Objective Response Rate (ORR)evaluated by the researchers

    Time frame: 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.

  6. The Clinical Benefit Rate (CBR) evaluated by the researchers

    Time frame: 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.

  7. 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))

    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.

  8. Antibody-drug conjugate (ADC)

    Time frame: 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.

  9. Total antibodies

    Time frame: 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.

  10. The small molecule toxin TO22723

    Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)

    The blood concentration of the small molecule toxin TO22723 in TOB2102.

  11. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Zhang, Doctor

CONTACT

[email protected]

022-65150123

Zhimin Shao, Doctor

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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