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Trial Title:
Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer
NCT ID:
NCT05576389
Condition:
Germline BRCA-mutated HER2-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fluzoparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab+Fluzoparib
Description:
Fluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of
each cycle
Arm group label:
Camrelizumab+Fluzoparib
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。
Criteria for 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.)
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast Cancer, Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Start date:
October 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05576389
