Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study

This study is an open-label, single-arm, multicenter clinical study. 64 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: Recruiting
• Conditions: Germline BRCA-mutated HER2-negative Breast Cancer
• Intervention / Treatment: Drug: Camrelizumab+Fluzoparib

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shu Wang, Dr.; Phone Number: 13801080201; Email: xiefei@pkuph.edu.cn
• Study Contact Backup: Name: Fei Xie, Dr.; Phone Number: 13121969425; Email: xiefei@pkuph.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Breast Cancer, Peking University People's Hospital
      • Contact: Shu Wang, Dr.; Phone Number: 13801080201; Email: shuwang@pkuph.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)
• Patients with bilateral breast cancer whose primary lesions all meet the inclusion criteria, or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the inclusion criteria on one side;
• 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;

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab+Fluzoparib; Fluzoparib combined with Carolizumab for 8 cycles of neoadjuvant therapy. Allowing the continued use of combination therapy or monotherapy with Carolizumab and fluzoparib during the adjuvant therapy phase, with an overall treatment duration not exceeding 12 months.	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 (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2028

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): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

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-034

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