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

NCT05761470 | Recruiting Phase 2

• 1 other identifier: 20220430GD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Her-2 Negative Breast Cancer; HRR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 32 weeks

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to 32 weeks

• Residual Cancer Burden (RCB)

  Up to 32 weeks

• Event-Free Survival (EFS)

  Up to 20 years

• Overall Survival (OS)

  Up to 20 years

• Safety of drugs

  Up to 32 weeks

Study Arms (1)

Camrelizumab, Fluzoparib and Nab-paclitaxel

EXPERIMENTAL

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.

Drug: Camrelizumab; Drug: Fluzoparib; Drug: Nab-paclitaxel

Interventions

Camrelizumab 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.

Camrelizumab, Fluzoparib and Nab-paclitaxel

Fluzoparib DRUG

Fluzoparib

Camrelizumab, Fluzoparib and Nab-paclitaxel

Nab-paclitaxel DRUG

Nab-paclitaxel

Camrelizumab, Fluzoparib and Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ying Lin: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; fluzoparib; 130-nm albumin-bound paclitaxel

Study Officials

• Ying Lin, MD

  Principal Investigator

  STUDY CHAIR

Central Study Contacts

Ying Lin, MD

CONTACT

+8602087755766; linying3@mail.sysu.edu.cn

Xiaying Kuang, MD

CONTACT

+8602087755766; kuangxy5@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of department

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: March 9, 2023
• Study Start: May 6, 2022
• Primary Completion: June 30, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

CN (1)