The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

Summary

This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression, death or intolerable toxicity. Tumor assessment was conducted according to RECIST 1.1 criteria.

Timeline

Start

2022-06

Primary completion

2025-12

Completion

2027-12

Drugs

Indications