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ACTIVE NOT RECRUITING
NCT05328440
PHASE2

Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.

Official title: Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer: a Single Arm, Dual Cohort, Prospective, Open Phase II Exploratory Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-05-20

Completion Date

2028-01-01

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

DRUG

Pyrotinib Maleate

once a day, 125mg each time, taking for 3 weeks, stopping for 1 week, 4 weeks as a cycle. It is recommended to take medicine at about the same time every day, take it with warm water, and fast at least 1 hour before and after taking medicine

DRUG

Dalpiciclib Isethionate Tablets

400mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 28 days as a cycle

DRUG

Inetetamab

the initial dose is 8mg / kg and the subsequent dose is 6mg / kg. It is administered intravenously for 21 days.

DRUG

Fulvestrant

fluvestrant is administered intravenously on the 1/15 day of the first cycle, and then on the first day of each cycle, 500mg / time, intravenously

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China