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.
Women aged 18 to 75 years, either pre-menopausal/post-menopausal or post-menopausal.
Histologically confirmed HR+/HER2- locally advanced or metastatic breast cancer. Specific definition: Immunohistochemical detection of ER > 10% positive tumor cells is defined as ER positive, PR > 10% positive tumor cells is defined as PR positive, and ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 ++ but negative after FISH detection without amplification is defined as HER2 negative;
Have not received any systemic treatment for local recurrence or metastatic diseases before.
Recurrence occurred more than 12 months after the completion of adjuvant endocrine therapy.
Any evidence of severe or uncontrollable systemic diseases, including active bleeding disorders, active infections (such as hepatitis B, hepatitis C and human immunodeficiency virus), or severe damage to bone marrow reserves or organ functions (such as liver and kidney damage).
Previous use of CDK4/6 inhibitors.
Active brain metastases or meningeal brain metastases.
Upper limb arterial blood pressure lower than 90/60 mmHg.
Single group
Treatment
Drugdalpiciclib:125mg once a day for 3 weeks and stop for 1 week. Q4W.
Treatment
DrugOlmesartan:20mg，po，qd，q4w
Treatment
DrugLetrozole：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.
Progession-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.
overall Survival
OS is defined as the time from enrollment to the patient's death due to any cause
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.
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
The Treatment-Emergent adverse event rate according to the Common Terminology Criteria for Adverse Events version 5.0
Safety
Click on the lead sponsor to view all of their trials.
