Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015126
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-08
Brief Title:
Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients
Sponsor:
Yan Xue
Organization:
Xian International Medical Center Hospital
Study Overview
Official Title:
Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
vinorelbine are one of the main chemotherapy drugs used in the treatment of advanced breast cancer It is available in oral form making it convenient to use and an ideal choice for rhythmic chemotherapy In advanced breast cancermetronomic oral vinorelbine chemotherapy has been the subject of several clinical studies with proven effectiveness and good safety showing great prospects for application
Considering the current lack of targeted efficient and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment and based on the preliminary efficacy of metronomic oral vinorelbine anlotinib and rhythmic chemotherapy in breast cancer we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer providing new data for the treatment of HER2-negative advanced breast cancer
Considering the current lack of targeted efficient and convenient drugs for HER2-negative advanced breast cancer in later lines of treatment and based on the preliminary efficacy of metronomic oral vinorelbine anlotinib and rhythmic chemotherapy in breast cancer we plan to explore the efficacy and safety of combining metronomic oral vinorelbine chemotherapy with anlotinib in the treatment of HER2-negative advanced breast cancer providing new data for the treatment of HER2-negative advanced breast cancer
Detailed Description:
Research Title A single-center open-label single-arm clinical study on the efficacy and safety of Changchun Ruibin rhythmic chemotherapy combined with anlotinib in HER2-negative advanced breast cancer
Study Drugs - metronomic oral vinorelbine 30mgcapsule 20mgcapsule - Anlotinib 12mgcapsule 10mgcapsule 8mgcapsule
Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer and to provide new data for later-line treatment of HER2-negative advanced breast cancer
Study Design A single-center open-label single-arm clinical study with a planned enrollment of 60 patients
Study Drugs - metronomic oral vinorelbine 30mgcapsule 20mgcapsule - Anlotinib 12mgcapsule 10mgcapsule 8mgcapsule
Research Objective To determine the efficacy and safety of metronomic oral vinorelbine chemotherapy combined with anlotinib in the treatment of HER2-negative advanced breast cancer and to provide new data for later-line treatment of HER2-negative advanced breast cancer
Study Design A single-center open-label single-arm clinical study with a planned enrollment of 60 patients
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