Breast Cancer
Conditions
Interventions
intervention group:Fluzoparib in combination with Dalciclib and AI, 1 cycle every 28 days for a total of 6 cycles.
Fluzoparib: 100 mg, po, bid (1 in the morning and 1 in the evening), administered con
Sponsors
Harbin Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal female breast cancer patients aged >=18 years. 2. histologically confirmed hormone receptor (HR) positive (ER>==1% and/or PR >=1% by immunohistochemistry) and HER2 negative by pathology. Follow the 2018 version of the ASCO- CAP HER2 negative interpretation guideline criteria. Immunohistochemistry (IHC) score of 0 or + or 2+ and negative in situ hybridisation (ISH) test (ISH amplification =90 g/L (no transfusion within 14 days); ANC >=1.5 x 10^9 /L; PLT >=90 x 10^9 /L; Liver and renal function: TBIL 50 ml/min (Cockcroft-Gault formula); 8.Women of childbearing potential must have had a negative pregnancy test (serum or urine) within 7 days prior to enrolment and voluntarily use an appropriate method of contraception during the observation period and for 4 months after the last dose of study drug; 9,Voluntary enrolment in the study with informed consent, good compliance and willingness to co-operate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Previous receipt of any form of anti-tumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.). 2.Concurrent receipt of any other anti-tumor therapy. 3.Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. 4.Stage IV breast cancer. 5.Breast cancer not confirmed by histopathological diagnosis. 6.History of other malignant tumors within the past 5 years, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix. 7.Severe dysfunction of major organs such as the heart, liver, or kidney. 8.Dysphagia, chronic diarrhea, intestinal obstruction, or presence of multiple factors affecting drug administration and absorption. 9.Participation in other drug clinical trials within 4 weeks prior to enrollment. 10.Known history of allergy to any component of the study drugs; history of immunodeficiency (including positive HIV test, hepatitis C virus [HCV] infection, active hepatitis B virus [HBV] infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation). 11.History of any cardiac disease, including: (1) clinically significant arrhythmias requiring drug treatment; (2) myocardial infarction; (3) heart failure; (4) other cardiac diseases deemed inappropriate for participation in this trial by the investigator, etc. 12.Pregnant or lactating female patients; female patients of childbearing potential with a positive baseline pregnancy test; or female patients of childbearing potential unwilling to use effective contraceptive measures throughout the trial period. 13.According to the investigator's judgment, concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study (including but not limited to severe hypertension uncontrolled by drugs, severe diabetes mellitus, active infection, etc.). 14.History of definite neurological or psychiatric disorders, including epilepsy or dementia. 15.Any other conditions deemed unsuitable for the patient to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate ;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast pathological complete response rate ;Postmenopausal Estrogen/Progestin Intervention Score;Objective Response Rate;Event-Free Survival; | — |
Countries
China
Contacts
Public ContactJinsong Wang
Harbin Medical University Affiliated Cancer Hospital
Outcome results
None listed