Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

September 23, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2028

Conditions
Locally Advanced Breast Cancer (LABC)
Interventions
DRUG

Pyrotinib Maleate Tablets + Dalpiciclib Isethionate Tablets + Standard Endocrine

"Pyrotinib Maleate Tablets: 320 mg/day administered continuously from the first day of the first course of treatment, orally within 30 minutes after breakfast, missed doses without refill, every 21 days as a cycle.~Dalpiciclib Isethionate Tablets: 125 mg orally every 28 days as a treatment cycle, with continuous medication for the first 3 weeks (Day 1 to Day 21), and rest (no medication) for the next 1 week (Day 22 to Day 28).~Endocrine therapy: The endocrine therapy drug is selected by the investigator."

All Listed Sponsors
lead

The First Affiliated Hospital of Xiamen University

OTHER