Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
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: Bevacizumab.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 18 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
Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
Overview
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
Interventions
- Drug Bevacizumab
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.
Primary outcome measures
- PCR [Time frame: 24 months]
Secondary outcome measures (3)
- ORR [Time frame: 24 months]
- AE Advese Event Advese Event breast conservation rates [Time frame: 24 months]
- BCR breast conservation rates [Time frame: 24 months]
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 4.
- 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;
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;
6\. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);
7\. The investigators determined that the patients were suitable for treatment with bevacizumab.
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.
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
- The Fourth Hospital of Hebei Medical University — Shijiazhuang
Identifiers
NCT: NCT05525767 · 2021198-1