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This is an prospective, multicenter, single-arm clinical study.
Prospective, multicenter, single-arm clinical study of chemotherapy combined with bevacizumab neoadjuvant therapy for early or locally advanced HER2-negative breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned Interventions | Experimental | Bevacizumab 10mg/Kg d1, 1/21d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PCR | pathologic complete response | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 24 months |
| AE Advese Event Advese Event breast conservation rates | Advese Event | 24 months |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuizhi Geng | Contact | 13503216325 | gengcuizhi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| BCR breast conservation rates | breast conservation rates | 24 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |