Breast cancer
Conditions
Interventions
experimental group:Dalpiciclib+Endocrine therapy
control group:Chemotherapy followed by endocrine therapy
Sponsors
Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Postmenopausal, premenopausal, or perimenopausal female patients aged >=18 years. 2.Female patients with pathologically confirmed hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, who are not eligible for curative-intent surgical resection or radiotherapy. 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2. 4.No prior systemic therapy received for the recurrent/metastatic stage, and presence of indications for chemotherapy; symptomatic visceral metastases, rapidly progressive disease, or visceral disease requiring urgent intervention are permitted. If any clinical signs or symptoms of visceral crisis are present, at least one of the following conditions must be met: pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastases; dyspnea caused by pleural effusion or pulmonary lymphangitis; elevated liver enzymes (> 2 × upper limit of normal [ULN]); rapidly elevated bilirubin > 1.5 × ULN in the absence of Gilbert’s syndrome or biliary obstruction; pathologically confirmed bone marrow metastases. 5.Sufficient bone marrow function, defined as follows:a) Absolute neutrophil count (ANC) >= 1,500/mm^3(1.5 × 10^9/L) (no growth factor used within 14 days);b) Platelet count (PLT) >= 100,000/mm^3(100 × 10^9/L) (no corrective treatment used within 7 days);c) Hemoglobin (Hb) >=8 g/dL (80 g/L) (no corrective treatment used within 14 days). 6.For patients with brain metastases, there must be other evaluable disease sites, and at least one of the following conditions must be satisfied: (a)Untreated brain metastases that do not require immediate local therapy; (b)Previously treated brain metastases. 7.For premenopausal female subjects or those who have not undergone surgical sterilization, a serum pregnancy test must be performed within 7 days before the first dose of study treatment, with a negative result. Additionally, they must be willing to either abstain from sexual activity or use a medically approved highly effective contraceptive method after signing the informed consent form, during the study period, and for 1 year after the last dose of study treatment. 8.Voluntary participation in the study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of CDK4/6 inhibitor treatment. 2.Patients who experienced recurrence within 2 years of adjuvant endocrine therapy. 3.Patients receiving concurrent anti-tumor therapy (e.g., traditional Chinese medicines or proprietary Chinese medicines containing anti-tumor components). 4.Patients with isolated bone metastases, regardless of whether the disease is recurrent/metastatic or newly diagnosed stage IV breast cancer. 5.Patients with active brain metastases. 6.Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV DNA) >= 2000 IU/ml; hepatitis C (positive hepatitis C antibody with hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection of the analytical method); or concurrent hepatitis B and hepatitis C co-infection. 7.Occurrence of any of the following conditions within 6 months before enrollment: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) class >=2 heart failure, persistent arrhythmia of grade = 2 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism, or new-onset thrombosis. 8.Severe infection within 4 weeks before the first dose of study treatment (e.g., requiring intravenous administration of antibiotics, antifungals, or antivirals in accordance with clinical practice guidelines); or unexplained fever > 38.5°C during screening or before the first dose. 9.Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption. 10.Known hypersensitivity to any of the drugs used in the combined treatment regimen of the study or any of their excipients. 11.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 12.Known history of psychotropic substance abuse or drug addiction. 13.Pregnant or lactating female patients. 14.Any other conditions deemed by the investigator to make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Overall survival rate;Time to Response;objective response rate, ORR;Duration of relief, DoR;Clinical benefit rate,CBR;Safety; | — |
Countries
China
Contacts
Public ContactLi Huihui
Cancer Hospital of Shandong First Medical University
Outcome results
None listed