NCT05576389 Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
| NCT ID | NCT05576389 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Germline BRCA-mutated HER2-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2022-10-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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。
Eligibility 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.)
Contact & Investigator
Shu Wang, Dr.
PRINCIPAL INVESTIGATOR
Breast Center, Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT05576389 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Germline BRCA-mutated HER2-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05576389 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05576389 currently recruiting?
Yes, NCT05576389 is actively recruiting participants. Contact the research team at xiefei@pkuph.edu.cn for enrollment information.
Where is the NCT05576389 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05576389 clinical trial?
NCT05576389 is sponsored by Peking University People's Hospital. The principal investigator is Shu Wang, Dr. at Breast Center, Peking University People's Hospital. The trial plans to enroll 64 participants.
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