NCT05431504

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

An Exploratory Trial of Dalpiciclib in Combination With Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Dalpiciclib in combination with endocrine therapy by Physicians choice	Dalpiciclib 150 mg orally once daily for 3 weeks, followed by 1 week off in each 4-week cycle. Endocrine therapy including but not limited to fulvestran, tanastrozole, letrozole or exemestane In regular doses

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2022-06-24
• Last updated: 2022-06-24

Locations

1 site across 1 country: China