Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

June 30, 2026

Conditions
CANCERBRAEST CANCERLate Frontline
Interventions
DRUG

Dalpiciclib,Toremifen

"1. Dalpiciclib : 150mg orally, once a day, taken for 3 weeks, stopped for 1 week, with a cycle of 4 weeks. It is recommended to take medication at the same time every day, with warm water for delivery. It is recommended to do so on an empty stomach and fast for at least 1 hour before and after taking the medication.~2. Toremifen: 60mg orally, once a day If it is a premenopausal or perimenopausal patient, it is necessary to combine with OFS (OFS includes bilateral ovariectomy or GnRHa drugs)."

All Listed Sponsors
lead

Tianjin Medical University Cancer Institute and Hospital

OTHER

NCT06495515 - Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study | Biotech Hunter | Biotech Hunter