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Trial Title:
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
NCT ID:
NCT05761470
Condition:
Her-2 Negative Breast Cancer
HRR Gene Mutation
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Fluzoparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle.
Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed
dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.
Arm group label:
Camrelizumab, Fluzoparib and Nab-paclitaxel
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
Fluzoparib
Arm group label:
Camrelizumab, Fluzoparib and Nab-paclitaxel
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel
Arm group label:
Camrelizumab, Fluzoparib and Nab-paclitaxel
Summary:
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.
Detailed description:
This is a prospective, single-center, open-label phase II clinical trial investigating
the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast
cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.
Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of
Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and
Fluzoparib (100mg BID) from the second cycle.
HRR gene mutation contains 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.
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lin, MD
Phone:
+8602087755766
Phone ext:
8212
Email:
linying3@mail.sysu.edu.cn
Start date:
May 6, 2022
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Ying Lin
Agency class:
Other
Source:
First Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761470
