Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 8:32 AM
Study NCT ID:
NCT03785704
Status:
UNKNOWN
Last Update Posted:
2020-01-22
First Post:
2018-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
Sponsor:
Peking Union Medical College
Organization:
Study Overview
Official Title:
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
Totally 60 subjects will be included in the study. The present study was aimed to observe and evaluate the effect of Xinmailong injection on reducing cardiovascular toxicity associated with adjuvant chemotherapy after breast cancer surgery. The primary endpoint was 6 months of cardiac safety. Secondary endpoints included 3 months of cardiac safety, adverse events (AE), severe adverse events (SAE), and DFS.
Detailed Description:
After signing the informed consent, the patients in the control group will receive Epirubicin 45mg/m2 d1, 2 + cyclophosphamide 600mg/ m2 d1, repeated every 14 or 21 days for 4 cycles, followed by paclitaxel 175 mg/m2 (or docetaxel 75 mg/m2) on day 1, repeated every 21 days for 4 cycles. Patients in the Xinmailong group were given 5 mg/kg of Xinmailong injection every cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen as those in the control group. The patients-general condition, vital signs, blood routine, liver and kidney function, electrocardiogram, myocardial enzymes, troponin, BNP and echocardiography should be examined every week. Breast ultrasound were performed every week. Chest CT were evaluated after 8 cycles of chemotherapy.
After adjuvant chemotherapy, adjuvant radiotherapy and endocrine therapy were given according to the situation, and long-term survival was observed.
The patients will be followed up for 5 years, once every 6 months with in 1-3 years, once every 12 months within 4-5 years.
After adjuvant chemotherapy, adjuvant radiotherapy and endocrine therapy were given according to the situation, and long-term survival was observed.
The patients will be followed up for 5 years, once every 6 months with in 1-3 years, once every 12 months within 4-5 years.
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?: