Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
Recruiting
Phase 2Interventional Study
Her-2 Negative Breast CancerHRR Gene Mutation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
Ying Lin · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.
Trial Locations
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Status
Eligibility Criteria
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…
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.
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