Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653972
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Efficacy and Safety of a Two-week Dosing Regimen of Vinorelbine Combined with Liposomal Doxorubicin in the Treatment of HER2-negative Advanced Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Liposomal Doxorubicin Combined with Vinorelbine in the Treatment of Advanced Metastatic Breast Cancer a Single-Center Prospective Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASOVCWDITHABC
Brief Summary:
With advancements in various treatment modalities the survival of breast cancer patients has continuously improved Patients with advanced breast cancer who have undergone multiple lines of therapy still have treatment options but standard treatment protocols are lacking Anthracyclines are a cornerstone in breast cancer treatment however their cumulative dose-related cardiac toxicity limits their use Liposomal doxorubicin exhibits comparable efficacy to conventional anthracyclines and is not affected by previous cumulative doses The combination of vinorelbine with liposomal doxorubicin shows reduced cross-toxicity and several studies have demonstrated the effectiveness of this regimen in metastatic HER2-negative breast cancer patients
Therefore we aim to explore whether optimizing the dosage and treatment cycle of this combination therapy can provide a viable treatment option for metastatic HER2-negative breast cancer patients who have previously received second-line or higher chemotherapy seeking a regimen that balances efficacy and safety
This study is a single-center single-arm Phase II clinical trial planned to enroll 30 metastatic HER2-negative breast cancer patients who have previously undergone second-line or higher chemotherapy Participants will receive an optimized regimen of liposomal doxorubicin combined with vinorelbine with safety assessed every cycle and efficacy evaluated every three cycles Treatment will continue until radiographic evidence indicates disease progression intolerable toxicity occurs informed consent is withdrawn or the investigator decides to discontinue treatment Following treatment each participant will undergo survival follow-up every three months until death loss to follow-up or withdrawal of consent
Therefore we aim to explore whether optimizing the dosage and treatment cycle of this combination therapy can provide a viable treatment option for metastatic HER2-negative breast cancer patients who have previously received second-line or higher chemotherapy seeking a regimen that balances efficacy and safety
This study is a single-center single-arm Phase II clinical trial planned to enroll 30 metastatic HER2-negative breast cancer patients who have previously undergone second-line or higher chemotherapy Participants will receive an optimized regimen of liposomal doxorubicin combined with vinorelbine with safety assessed every cycle and efficacy evaluated every three cycles Treatment will continue until radiographic evidence indicates disease progression intolerable toxicity occurs informed consent is withdrawn or the investigator decides to discontinue treatment Following treatment each participant will undergo survival follow-up every three months until death loss to follow-up or withdrawal of consent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None