This study is a prospective, single-arm, multicenter phase II clinical trial. The study plans to enroll 40 patients with HR+/HER2- advanced breast cancer to explore the efficacy and safety of patients receiving olmesartan, dalpiciclib and aromatase inhibitor treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
dalpiciclib:125mg once a day for 3 weeks and stop for 1 week. Q4W.
Olmesartan:20mg,po,qd,q4w
Letrozole:2.5mg,q4w or Anastrozole:1mg,q4w or Exemestane:25mg,q4w or Fulvestrant:Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGProgession-free survival
PFS is defined as the time from enrollment to the first imaging disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.
Time frame: Up to 2 years
overall Survival
OS is defined as the time from enrollment to the patient's death due to any cause
Time frame: up tp 3 years
Objective response rate(ORR)
ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.
Time frame: up to 1 years
Disease control rate(DCR)
ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) and stable disease(SD) assessed by the investigator in accordance with the RECIST 1.1 criteria
Time frame: up to 1 years
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