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

Summary

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

Timeline

Start

2024-02-05

Primary completion

2025-05-08

Completion

2028-02

Outcome

Met primary endpoint

paper lower limit of the 90% CI (Clopper-Pearson exact binomial test) for tpCR rate exceeded 40% PMID 41289548 ↗

paper The tpCR rates were 57.7% (15 of 26 [90% CI, 43.2 to 71.3]; P = .04) for cohort 1 PMID 41289548 ↗

paper 76.9% (20 of 26 [90% CI, 62.3 to 87.6]; P < .01) for cohort 2 PMID 41289548 ↗

paper 61.5% (16 of 26 [90% CI, 46.5 to 74.8]; P = .02) for cohort 3 PMID 41289548 ↗

paper 69.2% (18 of 26 [90% CI, 54.6 to 81.3]; P < .01) for cohort 4 PMID 41289548 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TQB2102	Monoclonal antibody	6 mg/kg	Intravenous
Subject	TQB2102	Monoclonal antibody	7.5 mg/kg	Intravenous

Indications