Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer

Hebei Medical University Fourth Hospital1 site in 1 country75 target enrollmentMarch 31, 2022

ConditionsSolid Tumor

InterventionsBevacizumab

DrugsBevacizumab

Overview

Phase: Phase 4
Intervention: Bevacizumab
Conditions: Solid Tumor
Sponsor: Hebei Medical University Fourth Hospital
Enrollment: 75
Locations: 1
Primary Endpoint: PCR
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an prospective, multicenter, single-arm clinical study.

Detailed Description

Prospective, multicenter, single-arm clinical study of chemotherapy combined with bevacizumab neoadjuvant therapy for early or locally advanced HER2-negative breast cancer

Registry

clinicaltrials.gov

Start Date

March 31, 2022

End Date

December 31, 2028

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hebei Medical University Fourth Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old;
•Signed the informed consent and volunteered to join the study with good compliance;
•3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) :
•HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than
•ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;
•4\. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0);
•5\. The main organs function well and meet the following standards:
•A) Hemoglobin (HGB)≥90g/L;
•B) Neutrophil absolute value (NEUT)≥1.5×109/L;
•C) Platelet count (PLT)≥ 100×109/L;

Exclusion Criteria

•Stage IV (metastatic) breast cancer;
•Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;
•Patients who are participating in other intervention studies;
•Women with confirmed pregnancy or lactation;
•According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.