Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer

NCT ID: NCT05576389

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-12-31

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。

Conditions

Germline BRCA-mutated HER2-negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab+Fluzoparib

Group Type: EXPERIMENTAL

Camrelizumab+Fluzoparib

Intervention Type: DRUG

Fluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle

Interventions

Camrelizumab+Fluzoparib

Fluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle

Intervention Type: DRUG

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shu Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Breast Center, Peking University People's Hospital

Locations

Breast Cancer, Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

MA-BC-II-035

Identifier Type: -

Identifier Source: org_study_id