Breast cancer
Conditions
Interventions
A:Chemotherapy: EC*4-T*4 or AC*4-T*4 regimen
Dosage: A: Doxorubicin liposomes, 30-35 mg/m2, E: Epirubicin 80-100 mg/m2, C: cyclophosphamide, 600 mg/m2, T: docetaxel 80-100 mg/m2 or paclitaxel liposome
B:Dalpiciclib combined with endocrine therapy (plus ovarian function suppression if premenopausal) for 1 cycle in 28 days, a total of 6 cycles.
Dosage: dalpiciclib 125 mg p.o. qd (21 days and 7 days o
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form for enrollment in the clinical study; 2) Diagnosed with invasive breast cancer; 3) Perimenopausal or postmenopausal women; 4) Pathological examination confirmed: HR strongly positive, and HER2 negative. Definition of HER2 negative: HER2(-,+), or HER2 (++) by IHC but negative or no amplification by FISH; Definition of strong HR positivity: the proportion of ER-positive tumor cells detected by immunohistochemistry is =50% and the proportion of PR-positive cell is =20% 5) Clinical stage: T1N1-2M0 or T2-3N0-2M0 (stage II-IIIa) 6) Patients without concurrent cardiac disease: baseline left ventricular ejection fraction (LVEF) =50%, no obvious cardiac disease (= NYHA I grade) 7) ECOG score of 0-1 points meets the indications and basic requirements for chemotherapy, and no dysfunction of major organs 8) Blood routine test within 1 week prior to enrollment is basically normal: Absolute neutrophil count (NEUT#) = 1.5×10^9/L; Absolute white blood cell count (WBC) = 3.0×10^9 /L; Platelets= 90×10^9 /L; Hemoglobin = 90g/L; 9) Liver and kidney function tests were basically normal within 1 week prior to enrollment: Total bilirubin (TBIL) = 1.5× upper limit of normal (ULN); Alanine aminotransferase and aspartate aminotransferase (ALT/AST) =3×ULN; Serum creatinine = 1.5× ULN or creatinine clearance (Ccr) = 60 ml/min. 10) Informed consent form signed by the patient and his/her legal representative, or informed consent signed by the patient and his/her family members, which is in accordance with the requirements of the Ethics Committee 11) Have good compliance
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; women of childbearing age who do not agree to use effective contraception during the study; 2) Those who have had a severe allergic reaction to any of the test drug components (NCI-CTCAE 5.0 grade greater than grade 3); 3) Patients with bilateral breast cancer or inflammatory breast cancer; 4) Patients diagnosed with tumor stage IV (metastatic) breast cancer; 5) With a history of congestive heart failure, unstable angina, arrhythmia or myocardial infarction; 6) Suffering from sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc.; 7) Patients with severe liver-related diseases, such as acute hepatitis, fulminant hepatitis, coagulation factor synthesis disorders, etc., and those who are positive for HBV surface antigen or HBV core antibody need to undergo peripheral blood hepatitis B virus DNA titer test < 1×10^3 IU/ml before enrollment; 8) Patients with a concomitant disease or any serious medical disorder that may affect the safety of the subject (e.g., active or uncontrollable infection, active or hepatobiliary disease requiring antiviral therapy); 9) Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and patients adherence to treatment; 10) Breast cancer patients who have ever received chemotherapy, endocrine therapy, or anti-HER2 biologic therapy (except for diagnostic biopsy of primary breast cancer); 11) Those who have undergone major surgical surgery 4 weeks before the trial or have suffered from major medical diseases and have not recovered; 12) Patients with unmeasurable tumors during treatment. 13) Patients that are not suitable to be enrolled in the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual cancer burden (RCB) 0-I; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease-free Survival (DFS);Overall Survival (OS);Breast Cancer Specific Survival (BCSS);Breast Conversation Surgery Rate;Preoperative endocrine prognostic index;pathologic complete response rate (pCR);Tumor shrinkage effect;Safety; | — |
Countries
China
Contacts
Public ContactTang Jun
Sun Yat-Sen University Cancer Center
Outcome results
None listed