Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer

Recruiting now · Phase 4

Conditions studied: Solid Tumor

In brief

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

Key facts

Study ID

NCT05525767

Run by

Hebei Medical University Fourth Hospital

People needed

75

Starts

2022-03-31

Expected to finish

2028-12-31

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• 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.

Where it is running

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)

Full record on ClinicalTrials.gov

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