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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Women only

Fluzoparib with Camrelizumab before surgery for BRCA-mutated, HER2-negative breast cancer

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

Run by Peking University People's Hospital · NCT05576389 · Data updated 2026-11-12

This study tests whether the drug combo fluzoparib and camrelizumab can shrink BRCA-mutated, HER2-negative breast tumors before surgery in eligible patients.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment64 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionsimmunotherapy, camrelizumab
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedOctober 1, 2022
Main results expectedApril 30, 2027
Study endsDecember 31, 2028
Registry record updatedJuly 21, 2026
Trial IDNCT05576389 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with germline BRCA1/BRCA2 mutations, HER2-negative early or locally advanced breast cancer (IHC 0/1+ or HER2 IHC2+ with no ISH amplification), measurable disease, ECOG 0–1, and at least one measurable lesion according to RECIST 1.1.

Probably not a fit

Patients without BRCA mutations, HER2-positive disease, non-measurable disease, or poor performance status may not benefit from this regimen.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open-label, single-arm study conducted at multiple centers. It enrolls about 64 patients with germline BRCA mutations and HER2-negative early or locally advanced breast cancer. Participants receive neoadjuvant fluzoparib in combination with camrelizumab to evaluate safety and preliminary efficacy in tumor reduction. Eligibility requires measurable disease, good performance status, and confirmed BRCA mutations; key exclusions include active metastatic disease and prior related therapies. The lead sponsor is Peking University People’s Hospital, with Jiangsu Hengrui Pharmaceutical Co., Ltd. as a collaborator.

Why it matters

Potential benefit: If successful, this approach could offer a new neoadjuvant option that may improve tumor response and potentially surgical outcomes for eligible patients.

How similar studies have gone: PARP inhibitors combined with PD-1/PD-L1 inhibitors have shown activity in BRCA-mutated breast cancers in early-phase settings, but this specific neoadjuvant, open-label, single-arm approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.)

Where it's running

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

Study contacts

  • Principal investigator: Shu Wang, Dr. — Breast Center, Peking University People's Hospital
  • Study coordinator: Shu Wang, Dr.
  • Email: xiefei@pkuph.edu.cn
  • Phone: 13801080201

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.