Dalpiciclib in HR+/HER2- ABC

Not yet recruiting

• Conditions: Advanced Breast Cancer
• Interventions: Drug: dalpiciclib

• Registration Number: NCT06301438
• Lead Sponsor: RenJi Hospital

Brief Summary

To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-02
• Study First Submitted QC: 2024-03-02
• Study First Posted: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16
• Study Start: 2024-04-25
• Primary Completion: 2025-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Histologically confirmed advanced breast cancer
• Hormone receptor-positive and human epidermal growth factor receptor 2-negative
• ECOG 0-1

Exclusion Criteria

• Pregnant or breastfeeding
• History of immunodeficiency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dalpiciclib	dalpiciclib	dalpiciclib oral day 1-21, every 28 days

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)	The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Adverse events	From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)	Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China