TQB2102 injection versus trastuzumab emtansine for HER2-positive advanced breast cancer

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

This trial tests whether TQB2102 injection works as well as trastuzumab emtansine for adults with HER2-positive unresectable or metastatic breast cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: trastuzumab
• Locations: 31 sites (Bengbu, Anhui and 30 other locations)
• Trial ID: NCT07008976 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, open-label, positive‑drug controlled, multicenter trial enrolled adults with HER2-positive unresectable locally advanced or metastatic breast cancer and ECOG performance status ≤1. Participants were randomly assigned 1:1 to receive either TQB2102 injection or trastuzumab emtansine, with treatment and follow-up per protocol. The primary endpoint was progression-free survival as determined by an Independent Review Committee. The trial was conducted at several hospitals in Anhui province, China.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 years old with histologically confirmed HER2-positive unresectable locally advanced or metastatic breast cancer, ECOG ≤1, and an expected survival of more than three months.

Not a fit: Patients who are HER2-negative, have poor performance status (ECOG >1), a life expectancy under three months, or contraindications to antibody‑drug conjugates are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, TQB2102 could provide an alternative HER2-targeted antibody‑drug conjugate that maintains similar disease control to trastuzumab emtansine.

How similar studies have performed: Trastuzumab emtansine (T-DM1) has demonstrated benefit in HER2-positive metastatic breast cancer, so comparing a new agent to this established therapy builds on prior successful approaches.

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.

Where this trial is running

Bengbu, Anhui and 30 other locations

• The First Affiliated Hospital of Anhui Medical University — Bengbu, Anhui, China (Not_yet_recruiting)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Shunyi Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Hospital Of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
• Affiliated Cancer Hospital Of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• Cancer Hospital Of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Hainan General Hospital — Haikou, Hainan, China (Not_yet_recruiting)
• The Fourth Hospital Of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Affiliated Cancer Hospital Of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital) — Jiamusi, Heilongjiang, China (Not_yet_recruiting)
• Anyang Cancer Hospital — Anyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital Of Henan University Of Science & Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The Second Hospital Of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Not_yet_recruiting)
• Affiliated Hospital Of Jining Medical University — Jining, Shandong, China (Not_yet_recruiting)
• Linyi Cancer Hospital — Linyi, Shandong, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Dazhopu Central Hospital — Dazhou, Sichuan, China (Not_yet_recruiting)
• Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Hangzhou Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Zhimin Shao, Doctor

Conditions Metastatic Breast Cancer