Neoadjuvant TQB2102 versus TCbHP for HER2-positive breast cancer

A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

This study will test whether TQB2102 given before surgery helps people with HER2-positive breast cancer as much as or better than the standard TCbHP treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 544 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 78 sites (Bengbu, Anhui and 77 other locations)
• Trial ID: NCT07043725 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically confirmed HER2-positive invasive breast cancer (clinical T2-4 any N or any T with N1-3, M0), ECOG performance status 0–1, adequate organ function, and willingness to receive neoadjuvant therapy and subsequent surgery are ideal candidates.

Not a fit: Patients with metastatic (stage IV) disease, inadequate major organ function, pregnancy or lactation, or inability to undergo planned surgery are unlikely to benefit from this neoadjuvant comparison.

Why it matters

Potential benefit: If successful, TQB2102 could offer an effective alternative neoadjuvant HER2-targeted option that increases complete response rates before surgery with acceptable safety.

How similar studies have performed: Previous large trials of dual HER2-targeted therapy (trastuzumab plus pertuzumab) combined with chemotherapy have improved pathologic complete response rates and clinical outcomes, and this study tests whether TQB2102 matches or improves on that standard.

Eligibility criteria

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 this trial is running

Bengbu, Anhui and 77 other locations

• 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)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Hospital Affiliated to Army Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Quanzhou First Hospital — Quanzhou, Fujian, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China (Not_yet_recruiting)
• Zhongshan Hospital Xiamen university — Xiamen, Fujian, China (Not_yet_recruiting)
• ZhangZhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• Gansu Wuwei Tumour Hospital — Wuwei, Gansu, China (Not_yet_recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Meizhou People's Hospital — Meizhou, Guangdong, China (Not_yet_recruiting)
• Shantou Central Hospital — Shantou, Guangdong, China (Not_yet_recruiting)
• Guigang City People's Hospital — Guigang, Guangxi, China (Not_yet_recruiting)
• Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center) — Nanning, Guangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• The Affiliated Cancer Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• First Hospital of QinHuangDao — Qinhuangdao, Hebei, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Jiamusi Cancer Hospital — Jiamusi, Heilongjiang, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjinag, China (Not_yet_recruiting)
• Anyang Tumor Hospital — Anyang, Henan, China (Not_yet_recruiting)
• The People's Hospital of Anyang City — Anyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital ZhuZhou Central South University — Zhuzhou, Hunan, China (Not_yet_recruiting)
• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• NanChang People's Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Jinzhou Medical University — Jinzhou, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital Of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Zhimin Shao, Doctor

Conditions HER2-positive Breast Cancer