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Trial Title:
Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
NCT ID:
NCT05525767
Condition:
Solid Tumor
Conditions: Official terms:
Bevacizumab
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
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.
Arm group label:
Assigned Interventions
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old;
2. 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:
1. Stage IV (metastatic) breast cancer;
2. Received treatment for the disease, including chemotherapy, endocrine therapy,
radiotherapy, immunotherapy, etc.;
3. Patients who are participating in other intervention studies;
4. Women with confirmed pregnancy or lactation;
5. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Cuizhi Geng, M.D.
Phone:
0311-6669 6310
Email:
gengcuizhi@hotmail.com
Start date:
March 31, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05525767
