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

NCT06198751 | Active Not Recruiting Phase 2

• 1 other identifier: TQB2102-II-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Breast pathological complete (bpCR) response

  Up to 12 months.

• Objective response rate (ORR)

  Up to 12 months.

• Event-free survival (EFS)

  Up to 60 months.

• Invasive Disease-free survival (IDFS)

  Up to 60 months.

• The occurrence rate of all adverse events (AEs)

  From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.

Study Arms (2)

6 mg/kg of TQB2102 for injection

EXPERIMENTAL

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

7.5 mg/kg of TQB2102 for injection

EXPERIMENTAL

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

Interventions

6.0 mg/kg of TQB2102 for injection DRUG

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

6 mg/kg of TQB2102 for injection

7.5 mg/kg of TQB2102 for injection DRUG

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

7.5 mg/kg of TQB2102 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• History of invasive breast cancer.
• Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
• Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
• Unhealed wounds or fractures.
• Ocular diseases deemed clinically significant by the investigator.
• Occurrence of arterial/deep venous thrombotic events within the last 6 months.
• History of substance abuse with inability to quit or individuals with mental disorders.
• ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
• Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
• 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:
• Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.

Sponsors & Collaborators

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

Study Sites (7)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Guizhou Cancer Hospital

Guiyang, Guizhou, 550001, China

Location

Harbin medical university cancer hospital

Harbin, Heilongjiang, 150040, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Li JJ, Zhang WJ, Zeng XH, Zhang QY, Chen L, Wu J, Liu GY, Wang ZH, Hu XB, Hu YY, Li ZL, Shao ZM. Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial. J Clin Oncol. 2026 Jan;44(1):20-30. doi: 10.1200/JCO-25-01153. Epub 2025 Nov 25.

  PMID: 41289548 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: February 5, 2024
• Primary Completion: May 8, 2025
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-02

Locations

CN (7)