Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer (EBC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 30, 2023

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2025

Conditions
Breast Cancer
Interventions
DRUG

Dalpiciclib

Dalpiciclib: Take 125 mg once daily for 3 weeks, then stop for 1 week. Each cycle is completed in 4 weeks. It is recommended to take the medication approximately at the same time each day, with warm water, preferably on an empty stomach. Fasting for at least 1 hour before and after medication is advised.

DRUG

Aromatase inhibitor

AI: Take according to the instructions provided.

DRUG

Docetaxel injection

Administered as a 75 mg/m2 intravenous infusion over approximately 30 minutes. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.

DRUG

Epirubicin Hydrochloride Injection

Administered as a 75 mg/m2 intravenous infusion. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.

DRUG

Cyclophosphamide injection

Administered as a 500 mg/m2 intravenous infusion. It is given every three weeks and dose reduction or treatment delay is allowed, up to a maximum delay of 3 weeks from the previous dose calculation. Treatment will be terminated if the delay exceeds this limit.

Trial Locations (1)

050011

RECRUITING

The Fourth Hospital of Hebei Medical University, Shijiazhuang

All Listed Sponsors
lead

Hebei Medical University Fourth Hospital

OTHER