Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer

Summary

This is a single-center Ib / II study of triple targeted drug combination (endocrine therapy，novel HER2-targeted small molecule inhibitor pyrotinib and CDK4/6 inhibitor dalpiciclib(SHR6390) ) as a first or second line of therapy in patients with relapsed/metastatic hormone receptor positive and HER2-positive breast cancer.

Timeline

Start

2019-05-12

Primary completion

2023-06-10

Completion

2025-12-10

Publications

• Zhang J, Meng Y, Wang B, Wu X, Zheng H, Hu J, Liu W, Chen W, Wang L, Cao J, Tao Z, Li T, Ni S, Yu Z, Sun L, Wang Y, Peng Q, Wang S, Hu X, Wang J, Wu Y, Hu X. Dalpiciclib combined with pyrotinib and endocrine therapy in women with ER-positive, HER2-positive advanced breast cancer: A prospective, multicenter, single-arm, phase 2 trial. PLoS Med. 2025 Jul 31;22(7):e1004669. doi: 10.1371/journal.pmed.1004669. eCollection 2025 Jul.
• Zhang J, Meng Y, Wang B, Wang L, Cao J, Tao Z, Li T, Yao W, Hu X. Dalpiciclib Combined With Pyrotinib and Letrozole in Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer (LORDSHIPS): A Phase Ib Study. Front Oncol. 2022 Mar 7;12:775081. doi: 10.3389/fonc.2022.775081. eCollection 2022.

Drugs

Indications