Neoadjuvant TQB2102 versus TCbHP for HER2-positive 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 randomized, open-label, positive-control phase III trial compares neoadjuvant TQB2102 with the standard TCbHP regimen (trastuzumab + pertuzumab + docetaxel + carboplatin) across multiple centers. Eligible patients receive assigned therapy before planned breast cancer surgery and are followed for tumor response and safety. Primary and secondary outcomes include total pathological complete response (tpCR), breast pathological complete response (bpCR), objective response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events. The study aims to demonstrate that TQB2102 has comparable or superior effectiveness and an acceptable safety profile versus the established TCbHP regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily participate in this study, sign the informed consent form, and have good compliance;
* Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months;
* Histologically or cytologically confirmed HER2-positive invasive breast cancer;
* Hormone receptor (HR) status confirmed;
* Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0;
* Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy;
* Major organ function is adequate, meeting specific criteria;
* Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion

Exclusion Criteria:

* Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
* Bilateral breast cancer or inflammatory breast cancer;
* History of invasive breast cancer or ductal carcinoma in situ;
* Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;
* Comorbidities and medical history:

  * Other malignancies within 5 years or currently;
  * Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1;
  * Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures;
  * Conditions affecting intravenous injection or blood sampling;
  * Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin \>325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment;
  * Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism;
  * Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
  * Significant cardiovascular disease, including；
  * Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment;
  * History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out;
* Tumor-related symptoms and treatment:

  * Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment;
  * Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment);
  * Prior taxane or carboplatin therapy for any malignancy;
  * Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment.
* Study treatment-related:

  * Severe hypersensitivity to monoclonal antibodies;
  * Uncontrolled active autoimmune disease within 2 weeks before study treatment;
  * Allergy to any study drug or its components/excipients;
  * Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines.
* Any condition judged by the investigator to jeopardize subject safety or study completion.

Where it's running

• Jiamusi Cancer Hospital
  Jiamusi, Heilongjiang, China Recruiting
• Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital
  Jinan, Shandong, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Not yet recruiting
• Anhui Provincial Cancer Hospital
  Hefei, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Wannan Medical University
  Wuhu, Anhui, China Not yet recruiting

+27 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Zhimin Shao, Doctor
• Email: szm@163.com
• Phone: 13524514617

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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.