Back to resultsNeoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation (IMPARP)
Primary Purpose
Her-2 Negative Breast Cancer, HRR Gene Mutation
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Fluzoparib
Nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Her-2 Negative Breast Cancer
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.
Sites / Locations
- First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab, Fluzoparib and Nab-paclitaxel
Arm Description
Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
Outcomes
Primary Outcome Measures
Pathologic Complete Response (pCR)
Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
Secondary Outcome Measures
Objective Response Rate (ORR)
ORR is defined as percentage of participants with Complete Response and Partial Response
Residual Cancer Burden (RCB)
Pathologilly assessed residual cancer burden according to MD Anderson protocol.
Event-Free Survival (EFS)
EFS was defined as the time from the date of randomization to the date of events from any cause.
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Safety of drugs
Adverse effects of the candidates according to NCI-CTCAE 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05761470
Brief Title
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
Acronym
IMPARP
Official Title
A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ying Lin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Her-2 Negative Breast Cancer, HRR Gene Mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab, Fluzoparib and Nab-paclitaxel
Arm Type
Experimental
Arm Description
Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Intervention Description
Fluzoparib
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel
Primary Outcome Measure Information:
Title
Pathologic Complete Response (pCR)
Description
Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
Time Frame
Up to 32 weeks
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as percentage of participants with Complete Response and Partial Response
Time Frame
Up to 32 weeks
Title
Residual Cancer Burden (RCB)
Description
Pathologilly assessed residual cancer burden according to MD Anderson protocol.
Time Frame
Up to 32 weeks
Title
Event-Free Survival (EFS)
Description
EFS was defined as the time from the date of randomization to the date of events from any cause.
Time Frame
Up to 20 years
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Up to 20 years
Title
Safety of drugs
Description
Adverse effects of the candidates according to NCI-CTCAE 5.0
Time Frame
Up to 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Lin, MD
Phone
+8602087755766
Ext
8212
Email
linying3@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaying Kuang, MD
Phone
+8602087755766
Ext
8212
Email
kuangxy5@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Lin, MD
Organizational Affiliation
Principal Investigator
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Lin, MD
Phone
+8602087755766
Ext
8212
Email
linying3@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
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