HR/HER2- patients with early stage breast cancer
Conditions
Interventions
Experimental group:Cedabine combined with palbociclib and exemestane as neoadjuvant therapy for HR+/HER2- early-stage breast cancer
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this clinical trial, sign a written informed consent form, understand this study and be willing to follow all trial procedures; 2. Female, aged >=18 years old and =10%; 5. At least one measurable lesion as defined by RECIST V1.1 criteria; 6. Planned for definitive surgical resection of breast cancer, i.e., breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy, or axillary lymph node dissection (ALND), and planned to receive neoadjuvant chemotherapy; 7. Expected survival >=3 months; 8. ECOG performance status score of 0-1 points; 9. The function of vital organs meets the following requirements (no blood components and cell growth factors have been used within 2 weeks prior to enrollment) a) Absolute neutrophil count (ANC) >=1.5×10^9/L, platelets (PLT) >=90×10^9/L, hemoglobin (Hb) >=90g/L; b) Total bilirubin (TBIL) 50 mL/min; c) Left ventricular ejection fraction (LVEF) >=50%, QT interval (QTcF) corrected by Fridericia's method <470 msec; d) INR<=1.5 times ULN, activated partial thromboplastin time (APTT) <=1.5 times ULN; 10. Negative baseline pregnancy test test for pregnant, lactating female patients or women of childbearing potential; or subjects of childbearing age who are willing to take effective contraceptive measures during the study and at least 6 months after the last dose;
Exclusion criteria
Exclusion criteria: 1.Those who had clinical symptoms of ascites, pleural effusion, pericardial effusion at the baseline stage, and required drainage, or who had undergone serous cavity drainage within 4 weeks before the first administration of the medication; 2.Breast cancer patients who have previously received systemic treatments such as chemotherapy, endocrine therapy, molecular targeted therapy or other clinical trial drugs, or who have undergone breast surgery (excluding diagnostic biopsies for primary breast cancer); 3.The subjects had previously been diagnosed with other malignant tumors within the past 5 years or simultaneously (excluding cured cases such as skin basal cell carcinoma, cervical carcinoma in situ, and thyroid cancer). 4.Those who underwent major surgical procedures 4 weeks before the trial and those who had received blood or blood components transfusions; 5.Active HBV and HCV infected individuals; excluding those with stable hepatitis B (with DNA titer not exceeding 500 IU/mL or copy number = II degree. 8.According to the researchers' assessment, there are accompanying diseases that pose a significant threat to patient safety or interfere with the completion of the study (such as severe hypertension, diabetes, thyroid disorders, active infections, etc.); 9.Unable to swallow, intestinal obstruction or other factors that affect the administration and absorption of medication; 10.Patients with mental illnesses, intellectual disabilities or those who cannot cooperate with the treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete cell cycle block at the time of surgery;Pathological complete response;Residual cancer burden;Preoperative endocrine prognostic index;Disease control rate; | — |
Countries
China
Contacts
Public ContactLuo Ting
West China Hospital of Sichuan University
Outcome results
None listed