Combination therapy for early breast cancer with HRR gene mutation

Is this trial a fit for you?

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

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination therapy involving Camrelizumab, Fluzoparib, and Nab-paclitaxel for neoadjuvant treatment in patients with Her-2 negative breast cancer and HRR gene mutations. The study is a prospective, single-center, open-label phase II trial that aims to enroll 66 eligible candidates. Participants will receive 8 cycles of Nab-paclitaxel, with the addition of Camrelizumab and Fluzoparib starting from the second cycle. The focus is on patients with specific pathogenic mutations in genes related to homologous recombination repair.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically documented Her-2 negative
* TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
* No distant metastatic disease
* Eastern Cooperative Oncology Group Performance Status: 0\~1
* HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.

Exclusion Criteria:

* Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
* Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
* Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
* Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
* Patients who have used immunosuppressive drug or corticosteroids within 14 days.
* Patients who have other diseases which researchers.
* Patients who allergy to any of the drugs in this trail.

Where it's running

• First Affiliated Hospital, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Ying Lin, MD
• Email: linying3@mail.sysu.edu.cn
• Phone: +8602087755766

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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.