NCT04486911

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

Active, enrolled Phase 2 Last updated 2 August 2022

What this trial tests

Phase 2 trial testing Pyrotinib maleate, SHR6390, letrozole in Breast Cancer in 89 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 July 2020

Primary endpoint
1 December 2026

30 December 2026

Quick facts

Lead sponsor	Shengjing Hospital
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	27 July 2020
Primary completion	1 December 2026
Estimated completion	30 December 2026
Sites	1 location across China

Drugs / interventions tested

• Pyrotinib maleate, SHR6390, letrozole — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Shengjing Hospital

Who can join

Adults 18 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer.
   Niu N, Qiu F, Xu Q, He G, et al · · 2022 · cited 27× · PMID 36396665 · DOI 10.1038/s41467-022-34838-w
2. Dalpiciclib partially abrogates ER signaling activation induced by pyrotinib in HER2⁺HR⁺ breast cancer.
   Bu J, Zhang Y, Niu N, Bi K, et al · · 2023 · cited 11× · PMID 36602226 · DOI 10.7554/elife.85246
3. Molecular classification of hormone receptor-positive /HER2-positive breast cancer reveals potential neoadjuvant therapeutic strategies.
   Liu C, Sun L, Niu N, Hou P, et al · · 2025 · cited 9× · PMID 40133264 · DOI 10.1038/s41392-025-02181-3
4. Advances in the intrinsic signaling pathway interactions and clinical translation of HR+/HER2+ breast cancer.
   Li X, Huang T. · · 2025 · cited 1× · PMID 40983817 · DOI 10.1007/s12282-025-01779-3
5. A Structured Classification of Pyrotinib-Containing Neoadjuvant Regimens for HER2-Positive Breast Cancer: Efficacy, Safety, and Regimen Selection
   Liu J, Peng X, Yang Y, Huang X, et al · · 2026
6. Alternate actions of CDK4/6 inhibitors beyond cell cycle blockade: unexplored roles in therapy resistance.
   Scordamaglia D, Talia M, Zicarelli A, Mondino AA, et al · · 2025 · PMID 41388212 · DOI 10.1007/s10555-025-10307-w
7. Dalpiciclib Partially Abrogates ER Signaling Activation Induced by Pyrotinib In HER2 ⁺ HR ⁺ Breast Cancer
   Bu J, Zhang Y, Niu N, Bi K, et al · · 2022 · DOI 10.1101/2022.12.07.519433