Neoadjuvant treatment for HER2 positive breast cancer using TQB2102

A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of TQB2102 for Injection for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

This study is testing an injection treatment called TQB2102 to see if it can help shrink tumors in people with HER2 positive breast cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Chongqing, Chongqing and 6 other locations)
• Trial ID: NCT06198751 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of TQB2102, an injection treatment, for patients with HER2 positive breast cancer. Participants will receive either 6.0 mg/kg or 7.5 mg/kg of TQB2102 before undergoing surgery. The study aims to determine how well this treatment works in shrinking tumors and improving surgical outcomes. Patients must meet specific criteria, including having confirmed HER2 positive invasive breast cancer and a good performance status.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed HER2 positive invasive breast cancer who have not received prior systemic anti-tumor therapy.

Not a fit: Patients with metastatic breast cancer or those unable to achieve curative surgical resection are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with HER2 positive breast cancer.

How similar studies have performed: Other studies have shown promising results with neoadjuvant therapies for HER2 positive breast cancer, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Voluntarily participate in this study and sign informed consent;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected survival of more than 3 months;
* Histologically confirmed invasive breast cancer, no history of any systemic anti-tumor therapy for breast cancer;
* Confirmed as HER2 positive;
* Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
* Agree to undergo breast cancer surgery when reaching the surgical criteria after neoadjuvant therapy;
* Major organ functions are good, meeting certain criteria;
* Agree to use contraception during the study and within 6 months after the study ends; female patients must have a negative serum pregnancy test within 7 days before enrollment and must be non-lactating.

Exclusion Criteria:

* IV stage metastatic breast cancer or deemed unable to achieve curative surgical resection through neoadjuvant therapy by other investigators.
* Bilateral invasive breast cancer.
* Coexisting diseases and medical history:

  1. History of invasive breast cancer.
  2. Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
  3. Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
  4. Unhealed wounds or fractures.
  5. Ocular diseases deemed clinically significant by the investigator.
  6. Occurrence of arterial/deep venous thrombotic events within the last 6 months.
  7. History of substance abuse with inability to quit or individuals with mental disorders.
  8. ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
  9. Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
  10. History of interstitial lung disease/pneumonia requiring intervention with steroid treatment, or current presence, or suspected interstitial lung disease/pneumonia during the screening period that cannot be ruled out by the investigator; individuals with pulmonary diseases deemed unsuitable for participation by the investigator.
* Tumor-related symptoms and treatment:

  1. Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
  2. Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
  3. Radiological evidence of tumor invasion into major vessels or judged by the investigator to be highly likely to invade major vessels during the subsequent study period, leading to fatal hemorrhage.
* Study treatment-related:

  1. Experienced severe hypersensitivity reactions after using monoclonal antibodies.
  2. Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
  3. Allergic to any component or excipient in any study drug.
* Participated in other clinical trials of anti-tumor drugs within 4 weeks before the start of the study.
* Deemed inappropriate for inclusion based on the investigator's judgment.

Where this trial is running

Chongqing, Chongqing and 6 other locations

• Chongqing Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Guizhou Cancer Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Harbin medical university cancer hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhimin Shao, Doctor

Conditions Breast Cancer