RecruitingPhase 4NCT05525767
Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
Sponsor
Hebei Medical University Fourth Hospital
Enrollment
75 participants
Start Date
Mar 31, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This is an prospective, multicenter, single-arm clinical study.
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- Age ≥18 years old;
- Signed the informed consent and volunteered to join the study with good compliance;
- , 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 4.
- ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;
- \. 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);
- \. 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;
- D) leukocyte ≥3.0×109/L;
- E) Total bilirubin \<1.5 ULN (upper limit of normal)
- F) Creatinine \< 1.5×ULN
- G) AST/ALT \< 1.5×ULN;
- \. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);
- \. The investigators determined that the patients were suitable for treatment with bevacizumab.
Exclusion Criteria5
- 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.
Interventions
DRUGBevacizumab
All subjects enrolled will receive bevacizumab .Subjects continued to take medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or discontinuation of medication at the discretion of the investigator.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05525767
Related Trials
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
NCT0430055658 locations
Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors
NCT074644571 location
Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
NCT068950311 location
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
NCT061717505 locations
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
NCT0710972614 locations