A Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of TPBC

NARecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

Conditions
Breast Neoplasms
Interventions
DRUG

Darcilide +AI (letrozole/anastrozole/Exemestane) + pyrrotinib

"Darcilie: 125mg orally once a day, taken for 21 days and stopped for 7 days, 28 days as a cycle.~AI: Letrozole: 2.5mg orally once daily, or anastrozole 1mg orally once daily, or exemestane 25mg orally once daily.~Pyrrotinib: Initial dose of 240mg in the first week, if diarrhea and other side effects can be tolerated, 320 mg can be added in the second week, once a day, oral administration within 30 minutes after breakfast, 21 days for 1 cycle~All investigational drugs should be used for disease progression or when patients have an intolerable adverse reaction or are withdrawn from the study for other reasons.~Oral pyrrotinib is recommended along with prophylactic antidiarrheal medication. Antidiarrheal regimen 1: Oral imodium (2 tablets/times, 2 times a day) from the first week, 1 tablet, 2 times a day from the second week. Antidiarrheal regimen 2: montmorillonite powder (3 times a day, 1 pack/time)+ whole intestine sheng (3 pills/time 2 times a day)."

Trial Locations (1)

215000

RECRUITING

The Second Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

Second Affiliated Hospital of Soochow University

OTHER