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New treatment option for Germline 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
ClinicalTrials.gov ID: NCT05576389
What this study is testing
What is Camrelizumab+Fluzoparib?
Camrelizumab+Fluzoparib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for germline brca-mutated her2-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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。
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- According to the definition of the latest ASCO/CAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by...
- 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)
You likely can't join 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...
- 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...
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C...
See the full eligibility 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 , or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the 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;
- 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.