Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03243838
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2017-08-05
Brief Title:
Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer LANCET A Multicenter Single-arm Phase II Trial
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LANCET
Brief Summary:
Triple-negative breast cancer TNBC is a special type of breast cancer endocrine therapy and targeted therapy are completely ineffective chemotherapy is currently the only effective treatment How to improve postoperative pathologic complete responsepCRof neoadjuvant chemotherapy is critical problem to prolong event-free survival EFS and overall survival OS of TNBC patients Apatinib is a new oral small molecule tyrosine protease inhibitor it is effective in inhibiting angiogenesis with a very low concentration So the standard neoadjuvant chemotherapy regimen of docetaxel and carboplatin combined with apatinib may improve the postoperative pCR and survival outcomes of TNBC patients Safety and tolerability assessed by number of grade 3 and 4 toxicities and hospitalizations
Detailed Description:
All enrolled patients were administered oral apatinib at a dose of 250 mg once daily and intravenously docetaxel 100 mgm2 every three weeks for four cycles followed by epirubicin 90 mgm2 plus cyclophosphamide 600 mgm2 every three weeks for four cycles All the treatments were continued until disease progression patient withdrawal or unacceptable toxic effects Granulocyte colony-stimulating factor G-CSF used for prophylaxis of febrile neutropenia was permitted according to the American Society of Clinical Oncology ASCO guidelines The biochemical and hematological indexes were evaluated every cycle Dose modifications of chemotherapy agents including dose interruptions and dose reductions were permitted due to certain adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None