Breast cancer
Conditions
Interventions
Test group:Abemaciclib combined with aromatase inhibitors
Sponsors
Liaoning Cancer Hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria to be eligible for the trial: 1. With HR+, HER2- breast cancer confirmed by histopathological examination of the primary lesion; patients with known hormone receptor status, with percentage of cells with positive ER = 10% and PgR expression = 1%; HER2-negative breast cancer defined according to Chinese Guidelines for HER2 Detection in Breast Cancer, the 2019 Version; 2. With Ki-67baseline > 10% confirmed by immunohistochemical examination of the primary lesion; 3. The clinical stage should be in the following clinical disease stages: T2 to T3, N0 to N2, M0, according to the 8th edition of the TNM classification of the American Joint Committee on Cancer (AJCC); 4. Have postmenopausal status, defined as meeting one of the following conditions: ? Age = 60 years at the time of screening for this study; ? Age < 60 years of age at the time of screening for this study and amenorrhea for at least 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; serum estradiol and follicle-stimulating hormone (FSH) levels must be in the postmenopausal range; ? Prior bilateral oophorectomy; 5. Adequate major organ function, including: 1) Hematology ? ANC = 1.5×10^9/L; ? PLT = 100×10^9/L; ? Hb = 90 g/L; Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. 2) Blood chemistry ? TBIL = 1.5 × ULN; Patients with Gilbert’s syndrome with a total bilirubin = 2.0 times ULN and direct bilirubin within normal limits are permitted. ? ALT and AST = 3 × ULN; ? Urea or blood urea nitrogen (BUN) = 1.5 × ULN, creatinine (Cr) = 1.5 × ULN; 6. With ECOG score 0 ~ 1; 7. Have not received CDK4/6 inhibitor therapy; 8. Participate in this study voluntarily, sign the informed consent form prior to any study-specific procedures and are able to follow study schedule during treatment and follow-up; 9. Are able to swallow oral medications.
Exclusion criteria
Exclusion criteria: Patients with any of the following will not be enrolled in the study: 1. The patient has inoperable locally advanced or inflammatory or metastatic or bilateral breast cancer are excluded; 2. Any prior systemic or regional treatment for primary invasive breast cancer; 3. The patient has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene; 4. The patient is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate). Appropriate washout period between last dose of exogenous hormone therapy and initiation of the trial is up to the investigator’s medical judgment (for example, applying 5 times the half-life elimination rule). Note: topical vaginal estrogen therapy is permitted if all other non-hormonal options are exhausted. 5. The patient has had major surgery within 14 days prior to initiation of the trial; 6. The patient has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea); 7. The patient has active systemic infections (for example, bacterial infection requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (for example known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment; 8. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest; 9. Patients with a history of venous thromboembolism (for example, deep venous thrombosis of the leg or arm and/or pulmonary embolism) will be excluded; 10. The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to initiation of the trial, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study; 11. Patients with serious uncontrolled diseases that seriously jeopardize the safety of patients or affect the completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.) as determined by the investigator; 12. No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy 13. With any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of PEPI=0; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor regression patterns;Objective response rate(ORR);Breast conserving surgery (BCS);Invasive disease free survival(iDFS);Safety; | — |
Countries
China
Contacts
Public ContactQiang Zhang
Liaoning Cancer Hospital
Outcome results
None listed