Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

NCT ID: NCT05761470

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2028-12-31

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.

Conditions

Her-2 Negative Breast Cancer; HRR Gene Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab, Fluzoparib and Nab-paclitaxel

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.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

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.

Fluzoparib

Intervention Type: DRUG

Fluzoparib

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel

Interventions

Camrelizumab

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

Fluzoparib

Fluzoparib

Intervention Type: DRUG

Nab-paclitaxel

Nab-paclitaxel

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ying Lin

OTHER

Sponsor Role: lead

Responsible Party

Ying Lin

director of department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying Lin, MD

Role: STUDY_CHAIR

Principal Investigator

Locations

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Lin, MD

Role: CONTACT

linying3@mail.sysu.edu.cn

+8602087755766 ext. 8212

Xiaying Kuang, MD

Role: CONTACT

kuangxy5@mail.sysu.edu.cn

+8602087755766 ext. 8212

Facility Contacts

Ying Lin, MD

Role: primary

linying3@mail.sysu.edu.cn

+8602087755766 ext. 8212

Other Identifiers

20220430GD

Identifier Type: -

Identifier Source: org_study_id