A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

NCT ID: NCT06198751

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2028-02-29

Brief Summary

To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6 mg/kg of TQB2102 for injection

6 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles.

Group Type: EXPERIMENTAL

6.0 mg/kg of TQB2102 for injection

Intervention Type: DRUG

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.

7.5 mg/kg of TQB2102 for injection

7.5 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles.

Group Type: EXPERIMENTAL

7.5 mg/kg of TQB2102 for injection

Intervention Type: DRUG

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.

Interventions

6.0 mg/kg of TQB2102 for injection

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.

Intervention Type: DRUG

7.5 mg/kg of TQB2102 for injection

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Harbin medical university cancer hospital

Harbin, Heilongjiang, China

Hunan Cancer Hospital

Changsha, Hunan, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

TQB2102-II-01

Identifier Type: -

Identifier Source: org_study_id