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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: 6.0 mg/kg of TQB2102 for injection; Drug: 7.5 mg/kg of TQB2102 for injection

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Chongqing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550001
      • Guizhou Cancer Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Harbin Medical University Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Liaoning Cancer Hospital & Institute
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 6.0 mg/kg of TQB2102 for injection; TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
Experimental: 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.	Drug: 7.5 mg/kg of TQB2102 for injection; TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total physiological complete response (tpCR)	The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.	Up to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast pathological complete (bpCR) response	The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer.	Up to 12 months.
Objective response rate (ORR)	The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.	Up to 12 months.
The occurrence rate of all adverse events (AEs)	The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
The severity of all adverse events (AEs)	The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA)	1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 6 Day1, Cycle 8 Day1, and 90 days after the end of the last infusion. Each cycle is 21 days.
Event-free survival (EFS)	The time from the date of surgery completion to the first occurrence of the following events，including disease progression precluding surgery, ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.	Up to 60 months.
Invasive Disease-free survival (IDFS)	The time from the date of surgery completion to the first occurrence of the following events，including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.	Up to 60 months.
Overall survival (OS)	The time from the date of surgery completion to death due to any cause.	Up to 60 months after study start

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Actual): May 8, 2025
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TQB2102-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No