Palbociclib + Letrozole Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

July 19, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

May 31, 2026

Conditions
Breast Cancer
Interventions
DRUG

palbociclib combined with letrozole

Endocrine group will receive palbociclib combined with letrozole: palbociclib (Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; license number: H20180040) 125 mg/d, every 28 days as a cycle (medication for 3 consecutive weeks and withdrawal for 1 week); letrozole (Novartis Pharma Schweiz AG, Stein, Switzerland; license number: H20140149) 2.5 mg/d, for 6 consecutive months.

DRUG

epirubicin combined with cyclophosphamide and sequential docetaxel

Chemotherapy group will receive epirubicin combined with cyclophosphamide and sequential docetaxel: epirubicin (Pfizer Wuxi Pharmaceutical Plant, Wuxi, China; license number: GYZZ H20000496), 90 mg/m2, intravenously, for 120 minutes, once every four weeks, totally four times; cyclophosphamide (Baxter Oncology GmbH, Halle, Germany; license number: H20160468), 600 mg/m2, once every four weeks, totally four times; sequential docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; license number: GYZZ J20150083) 75 mg/m2, intravenously, for 120 minutes, once every four weeks, totally four times.

Trial Locations (1)

110004

Shengjing Hospital of China Medical University, Shenyang

All Listed Sponsors
lead

Shengjing Hospital

OTHER