This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
CDK4/6 inhibitors:dalpiciclib,palbociclib,abemaciclib,ribociclib
No. 119 Zhuodaoquan South Road
Wuhan, Hubei, China
Objective Response Rate (ORR)
ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
Time frame: up to 24 weeks
change in Ki67
change in Ki67 from baseline to end of treatment
Time frame: up to 24 weeks
complete cell cycle arrest
The proportion of patients with Ki-67≤2.7% on day 15 of cycle 1 treatment
Time frame: up to 4 weeks
Invasive disease free survival(iDFS)
Time from adjuvant therapy to disease recurrence in patients with invasive disease
Time frame: up to 3 years
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