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

NCT05576389 | Recruiting Phase 2

• 1 other identifier: MA-BC-II-034
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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。

Conditions

Germline BRCA-mutated HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• tpCR（ypT0/is ypN0）

  total pathological complete response

  6 months

Study Arms (1)

Camrelizumab+Fluzoparib

EXPERIMENTAL

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

Interventions

Camrelizumab+Fluzoparib DRUG

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

Camrelizumab+Fluzoparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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;

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Breast Cancer, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Officials

• Shu Wang, Dr.

  Breast Center, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Wang, Dr.

CONTACT

13801080201; xiefei@pkuph.edu.cn

Fei Xie, Dr.

CONTACT

13121969425; xiefei@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 12, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

CN (1)