Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

October 1, 2027

Study Completion Date

April 1, 2028

Conditions
Breast CancerEarly-stage Breast Cancer
Interventions
DRUG

Dalpiciclib

Dalpiciclib, oral administration, 125g each time, once daily, days 1-21, with a 28-day cycle (3 weeks on/1 week off). Continuous medication for 6 cycles, or disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgement, patient would no longer benefit from the treatment.

DRUG

Letrozole

2.5 mg, oral, once daily (continuously), with a 28-day cycle. Continuous medication for 6 cycles, or disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first. Refer to drug instructions for specific usage

Trial Locations (1)

Unknown

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Peking University

OTHER

NCT06650748 - Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer | Biotech Hunter | Biotech Hunter