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

Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer: An Open-label, Single-arm, Multicenter Trial

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。

Study Overview

• Status: Enrolling by invitation
• Conditions: Germline BRCA-mutated HER2-negative Breast Cancer
• Intervention / Treatment: Drug: Camrelizumab+Fluzoparib

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Breast Cancer, Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Camrelizumab+Fluzoparib	Drug: Camrelizumab+Fluzoparib; Fluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tpCR（ypT0/is ypN0）	total pathological complete response	6 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Shu Wang, Dr., Breast Center, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2022
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): December 31, 2026

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (ACTUAL): October 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MA-BC-II-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No