Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05761470

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

Led by Ying Lin · Updated on 2023-03-09

66

Participants Needed

1

Research Sites

347 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed Her-2 negative breast cancer
  • TNM stage: T1c with N1-N2; T2-4 with N0-N2; or any T with N3
  • No distant metastatic disease
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Presence of at least one pathogenic or likely pathogenic HRR gene mutation in germline or somatic BRCA1, BRCA2, PALB2, ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, or RAD51D genes
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women or those unwilling to use contraception
  • History of other malignant diseases within the past 2 years, except cured skin basal cell carcinoma, breast carcinoma in situ, or cervical carcinoma in situ
  • Psychiatric disorders, peripheral or central nervous system diseases, or any condition affecting ability to consent or participate
  • History of myocardial infarction, congestive heart failure, or other serious heart diseases
  • Use of immunosuppressive drugs or corticosteroids within 14 days prior to enrollment
  • Any other diseases as determined by the researchers
  • Allergy to any of the study drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510080

Actively Recruiting

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Research Team

Y

Ying Lin, MD

CONTACT

X

Xiaying Kuang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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