Clinical trial NCT05576389: Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer
Official title: Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer: An Open-label, Single-arm, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Germline BRCA-mutated HER2-negative Breast Cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2022-10-12
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, single-arm, multicenter clinical study. 94 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。


Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
* Histopathologically confirmed early or locally advanced HER2-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:

HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; Tumor stage: II-III; Primary tumor size: ≥ 1 cm Nodal Status: N0-3

* ECOG score 0 \~ 1;
* Centrally confirmed BRCA1 or BRCA2 germline mutation;
* At least one measurable lesion according to RECIST 1.1
* Eligible level of organ function

Exclusion Criteria:

* Patients with metastatic breast cancer or bilateral breast cancer;
* Patients with inflammatory breast cancer;
* Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy or tumor embolization;
* Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other therapies against PD-1/PD-L1 inhibitors;
* Previously received PARP inhibitors;
* 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.)

Primary outcomes:
measure: tpCR（ypT0/is ypN0）
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Breast Cancer, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Breast Center, Peking University People's Hospital
name: Shu Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: