Dalpiciclib in HR+/HER2- ABC

Advanced Breast Cancer Clinical Trial

Official title:

Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06301438
• Other study ID #: LY2024-022-A
• Status: Not yet recruiting
• Start date: April 25, 2024
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: Wenjin Yin
• Phone: 86(21)68385569
• Email: yinwenjin[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 103
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• dalpiciclib
dalpiciclib oral day 1-21, every 28 days

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	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.	From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)
Secondary	Adverse events	Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.	From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)