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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Anhui Provincial Cancer Hospital
  Hefei, Anhui, China Recruiting
• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Bengbu, Anhui, China Not yet 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

Study contacts

• Study coordinator: Zhimin Shao, Doctor
• Email: szm@163.com
• Phone: 021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.