Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
According to the definition of the latest ASCO/CAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by histopathology meets the following conditions:
* HER2 negative: IHC 0/1+or IHC2+with no amplification of ISH;
* Primary tumor size: ≥ 1cm
* Lymph node status: N0-3
* Inflammatory breast cancer patients with measurable lesions (according to RECIST 1.1 standard)
The hormone receptor status is known;
ECOG score 0-1;
Carrying BRCA1 or BRCA2 germline pathogenic mutations or suspected pathogenic mutations;
According to RECIST 1.1 standard, at least one measurable lesion is present;
You may not be if
Tumor related symptoms and treatment
* Recurrent or metastatic breast cancer;
* Participated in other drug trials or received any anti-tumor therapy, including endocrine therapy, bisphosphate therapy, immunotherapy, biological therapy, or tumor embolization, within 4 weeks prior to enrollment;
* Previously received treatment for PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
* Previously received PARP inhibitor treatment (excluding those who have completed PARP inhibitor treatment for ovarian cancer for at least 5 years without recurrence or metastasis);
Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;
Confirmed history of heart failure or systolic dysfunction (LVEF \< 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication
Female patients who are pregnant or lactating
History of definite neurological or psychiatric disorders, including epilepsy or dementia
Presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)
Clareo Health | Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
