Home
Clinical Trials
Clinical Trial of TQB2102 for...

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

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

NCT07003074

Breast Cancer

RECRUITING PHASE3

The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

NCT06452706

Breast Cancer

RECRUITING PHASE2

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

NCT07047365

HER2-positive Advanced Breast Cancer

RECRUITING PHASE3

A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer

NCT06115902

Breast Cancer

RECRUITING PHASE1

A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

NCT06198751

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TQB2102 Injection

The drug is administered by intravenous infusion, at a dose of 6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle.

Group Type EXPERIMENTAL

TQB2102 Injection

Intervention Type DRUG

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

Trastuzumab Emtansine for Injection

The drug is administered by intravenous infusion, at a dose of 3.6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle.

Group Type ACTIVE_COMPARATOR

Trastuzumab Emtansine for Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TQB2102 Injection

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

Intervention Type DRUG

Trastuzumab Emtansine for Injection

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.