NCT06176534View on ClinicalTrials.gov

Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 20, 2025

Study Completion Date

December 20, 2026

Conditions
Advanced Breast CancerTreatmentHR Low/HER2 Negative
Interventions
DRUG

Experimental: chemotheyapy

nab-paclitaxel 130mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2, followed by nab-paclitaxel 130mg/m2，day 1 and day 8 or Capecitabine from day1 to DAY 14 Vinorelbine 25mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2，from day1 to DAY 14

DRUG

Active Comparator: endocrine therapy

palbociclib 125mg per day for 21days Dalpiciclib 150mg per day for 21days Letrozole 2.5mg per day Anastrozole 1mg per day fulvestrant 500mg per 28 days

Trial Locations (1)

Unknown

RECRUITING

Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

Henan Cancer Hospital

OTHER_GOV