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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 20, 2022

Primary Completion Date

June 1, 2024

Study Completion Date

January 1, 2026

Conditions
Breast Neoplasms
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

Trial Locations (1)

Unknown

RECRUITING

Henan Cancer Hospital, Zhengzhou

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

lead

Henan Cancer Hospital

OTHER_GOV