Breast Cancer
Conditions
Interventions
chemotherapy-insensitive high-risk luminal breast cancer:Dalpiciclib+aromatase inhibitor+/-goserelin
Sponsors
Breast Surgery of the First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Postmenopausal, premenopausal or perimenopausal women aged =18 2.Operable patients with ER+ (>10%), HER2- invasive breast carcinomas, regardless of PR level. HER2- was defined as IHC score of 0+, or IHC score of 2+ with negative ISH (amplification ratio <2.0) according to 2018 ASCO-CAP guideline 3.Initially treated patients with stage II-III according to AJCC criteria (8th edition) and high risk of recurrence and metastasis(reference definition : ? cN1 patients meet one of the following criteria: tumor size=5 cm, G3 or Ki-67 =20%;? cN2-3 patients ) 4.Without known hypersensitivity to Dalpiciclib or its excipients 5.A ECOG PS score of 0-1 6.With the ability to swallow the study drug 7.With sufficient organ function, including (1) bone marrow function: ANC = 1.5 x 10^9/L (without growth factors within 14 days); PLT = 100 x 10^9/L (without corrective therapy within 7 days); Hb = 100 g/L (without corrective therapy within 7 days); (2)liver and kidney function: TBIL = ULN; ALT and AST = 3 × ULN (ALT and AST = 5 × ULN for those with liver metastases); BUN and Cr = 1.5×ULN; 3) QT interval = 480 ms from the 12-lead electrocardiogram 8.Volunteered to participate in this study, signed informed consent, with good compliance and willingness to follow-up
Exclusion criteria
Exclusion criteria: 1.Concurrently receiving any anti-tumor treatments other than that prescribed by the protocol 2.Known hypersensitivity to the study drug or its excipients 3.Patients with bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4.Patients with stage IV breast cancer 5.Other malignancies in the last five years 6.Patients with severe liver, kidney, or heart dysfunction 7.Inability to swallow, with chronic diarrhea, with intestinal obstruction, or with other factors affecting drug administration and absorption 8.Participated in other clinical trials within 4 weeks before enrollment 9.History of immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation 10.History of any cardiac disease, including: (1) arrhythmias requiring drug treatment or of clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease to be inappropriate for this trial judged by the investigator 11.Women who are pregnant or breastfeeding, women of childbearing potential who test positive for pregnancy test at baseline, or women of childbearing potential who are unwilling to use effective contraception during the study 12.With serious concomitant disease that endanger safety, or interferes with the ability to complete the study judged by the investigator (including, but not limited to, uncontrolled hypertension, severe diabetes, active infection, etc.) 13.History of neurological or psychiatric disorders, including epilepsy or dementia, or any other condition inappropriate for this study deemed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative endocrine prognostic index(PEPI) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual cancer burden (RCB);Complete cell cycle arrest (CCCA);Changes in Ki-67;Objective response rate (ORR);iDFS; | — |
Countries
China
Contacts
Public ContactChen Bo
The First Hospital of China Medical University
Outcome results
None listed