RecruitingPhase 2

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

China64 participantsStarted 2022-10-01

Plain-language 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。

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

tpCR（ypT0/is ypN0）

Timeframe: 6 months

Trial details

NCT IDNCT05576389

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Shu Wang, Dr.

13801080201 xiefei@pkuph.edu.cn

View on ClinicalTrials.gov More Germline BRCA-mutated HER2-negative Breast Cancer trials