Pyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial

Summary

The emergence of CDK4/6 inhibitors has brought hope to breast cancer patients resistant to endocrine therapy. In the mouse model, pyrotinib maleate combined with CDK4/6 inhibitor exhibits higher anti-tumor activity than any anti-tumor drug alone. Moreover, the toxicity of the combined therapy does not increase compared with monotherapy. This provides a good preclinical model for the treatment of breast cancer by pyrotinib maleate combined with CDK4/6 inhibitor. Based on above, it is hypothesized that pyrotinib maleate, CDK4/6 inhibitor SHR6390 and aromatase inhibitor letrozole in combination can provide a better neoadjuvant strategy for stage II-III triple-positive breast cancer.

Timeline

Start

2020-07-27

Primary completion

2026-12-01

Completion

2026-12-30

Publications

• Bu J, Zhang Y, Niu N, Bi K, Sun L, Qiao X, Wang Y, Zhang Y, Jiang X, Wang D, Ma Q, Li H, Liu C. Dalpiciclib partially abrogates ER signaling activation induced by pyrotinib in HER2+HR+ breast cancer. Elife. 2023 Jan 5;12:e85246. doi: 10.7554/eLife.85246.

Drugs

Indications