Breast Cancer
Conditions
Interventions
Intervention group:Fluzoparib
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Ages between 18 and 75 years old; 2.The central laboratory confirms the presence of a pathogenic or likely pathogenic germline mutation in the BRCA1 or BRCA2 gene; 3.Histopathologically confirmed HER2-negative early or locally advanced invasive breast cancer, meeting the following conditions: 1) HER2-negative: IHC 0/1+ or IHC 2+ but ISH negative; 2) TNM staging: T1c, N1-N2; or T2-4, N0-N2; or any T, N3; 4.At least one measurable lesion according to RECIST 1.1; 5.No signs of distant metastasis; 6.ECOG score of 0 to 1; 7.Organ function levels must meet the following requirements: 1)Absolute neutrophil count >=1.5×10^9/L; 2)Platelets >=100×10^9/L; 3)Hemoglobin >=90g/L; 4)Serum albumin >=3g/dL; 5)Total bilirubin <=1.5 times the upper limit of normal (ULN); 6)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 times ULN; 7)Serum creatinine <=1.5 times ULN; 8.Women of childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment and must be willing to use a medically recognized, highly effective contraceptive method during the study period and for 3 months after the last administration of the study drug. 9.The subject voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Metastatic breast cancer; 2.Inflammatory breast cancer; 3.Participation in any other drug trial or receipt of any anti-breast cancer therapy, including chemotherapy, endocrine therapy, bisphosphonate therapy, immunotherapy, etc., within 4 weeks prior to enrollment; 4.Previous treatment with PARP inhibitors; 5.Diagnosis of any other malignant tumor within the past 2 years, excluding cured carcinoma in situ of the cervix, in situ breast cancer, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.; 6.Patients who have used immunosuppressive drugs within 14 days prior to the first administration of the study drug, excluding inhaled corticosteroids or physiological doses of systemic corticosteroid hormones (i.e., no more than 10mg/day of prednisone or the biological equivalent of other corticosteroids); 7.Patients with mental, neurological, severe cardiovascular or cerebrovascular diseases, or any other diseases that would affect the ability to give informed consent or participate in this study; 8.Known allergy to the study drug or any of its excipients; 9.Pregnant, breastfeeding, or patients who refuse contraception. 10.Any other circumstances deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TpCR (ypT0/is ypN0); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of gene expression (baseline vs. 2-cycle treatment vs. surgery);BpCR (ypT0/is);RCB;ORR;EFS;OS;AE;SAE;ECOG score;Vital signs;Physical examination;Laboratory value;ECG;Echocardiography; | — |
Countries
China
Contacts
Public ContactYuntao Xie
Beijing Cancer Hospital
Outcome results
None listed