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Recruiting NCT05761470

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

Phase II Interventional Her-2 Negative Breast Cancer HRR Gene Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab, Fluzoparib, Nab-paclitaxel.
Who it may be relevant to
Registry conditions: Her-2 Negative Breast Cancer, HRR Gene Mutation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 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.
  • Drug Fluzoparib
    Fluzoparib
  • Drug Nab-paclitaxel
    Nab-paclitaxel

Primary outcome measures

  • Pathologic Complete Response (pCR) [Time frame: Up to 32 weeks]
Secondary outcome measures (5)
  • Objective Response Rate (ORR) [Time frame: Up to 32 weeks]
  • Residual Cancer Burden (RCB) [Time frame: Up to 32 weeks]
  • Event-Free Survival (EFS) [Time frame: Up to 20 years]
  • Overall Survival (OS) [Time frame: Up to 20 years]
  • Safety of drugs [Time frame: Up to 32 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • First Affiliated Hospital, Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT05761470 · 20220430GD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗