Back to resultsClinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
Primary Purpose
Breast Neoplasms, Cardiac Event, Chemotherapeutic Toxicity
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Xinmailong Injection
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Xinmailong injection, anthracycline induced cardiac toxicity
Eligibility Criteria
Inclusion Criteria:
- age ≥18 years, female;
- after radical mastectomy, EC - T adjuvant chemotherapy is planned.
- No relevant treatment (such as antineoplastic therapy, immunotherapy, etc.) that may affect the outcome of treatment was received before admission.
- ECOG PS score: 0-2 points;
Laboratory criteria:
white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L.
- platelet (>100 *109/L); hemoglobin (>10g/dL); serum creatinine (<1.5 *normal value) upper limit (ULN); aspartate aminotransferase (AST) (<2.5 *ULN); alanine aminotransferase (ALT) (<2.5 *ULN); total bilirubin (<1.5 *ULN); serum creatinine (<1.5 *ULN); the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion Criteria:
- cockroach or xinmailong allergy (including xinmailong test positive).
- Pregnant or lactation woman
- severe bleeding tendency;
- With mental disease
- With severe infection or active gastrointestinal ulcers
- allergic to chemotherapeutic agents;
- Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ).
- With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
- taking part or participating in other clinical trials within one month.
- previous history of severe cardiovascular disease or cardiovascular disease risk factors were ≥ 4.
Sites / Locations
- National Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Xinmailong injection group
control group
Arm Description
given 5 mg/kg of Xinmailong injection every cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen (EC-T) as those in the control group.
receive conventional EC-T regimen chemotherapy (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).
Outcomes
Primary Outcome Measures
The rate of no cardiac events during chemotherapy
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) .No cardiac events were defined until all relevant indicators (Electrocardiograph, Echcardiography and myocardial enzyme) were normal during chemotherapy.
Secondary Outcome Measures
Disease-free survival (DFS)
The time between the start of a randomized clinical trial and the onset of disease recurrence or death from any cause
Full Information
NCT ID
NCT03785704
First Posted
December 5, 2018
Last Updated
January 20, 2020
Sponsor
Peking Union Medical College
1. Study Identification
Unique Protocol Identification Number
NCT03785704
Brief Title
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
Official Title
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Cardiac Event, Chemotherapeutic Toxicity
Keywords
Xinmailong injection, anthracycline induced cardiac toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Totally 60 subjects will be included in the study.Random assignment was 1:1 to Xinmailong injection group and control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xinmailong injection group
Arm Type
Experimental
Arm Description
given 5 mg/kg of Xinmailong injection every cycle on d0, d1, d2, d3, d4 on the same chemotherapy regimen (EC-T) as those in the control group.
Arm Title
control group
Arm Type
No Intervention
Arm Description
receive conventional EC-T regimen chemotherapy (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).
Intervention Type
Drug
Intervention Name(s)
Xinmailong Injection
Intervention Description
Xinmailong injection is extracted, separated, purified and refined from Periplaneta americana. It is the second class of new drugs and the only small molecular bioactive peptide preparation approved by the State Pharmaceutical Administration (P.R.China) for the prevention and treatment of heart failure. Its main constituents include complex nucleoside bases and binding amino acids.
Primary Outcome Measure Information:
Title
The rate of no cardiac events during chemotherapy
Description
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) .No cardiac events were defined until all relevant indicators (Electrocardiograph, Echcardiography and myocardial enzyme) were normal during chemotherapy.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
The time between the start of a randomized clinical trial and the onset of disease recurrence or death from any cause
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥18 years, female;
after radical mastectomy, EC - T adjuvant chemotherapy is planned.
No relevant treatment (such as antineoplastic therapy, immunotherapy, etc.) that may affect the outcome of treatment was received before admission.
ECOG PS score: 0-2 points;
Laboratory criteria:
white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L.
platelet (>100 *109/L); hemoglobin (>10g/dL); serum creatinine (<1.5 *normal value) upper limit (ULN); aspartate aminotransferase (AST) (<2.5 *ULN); alanine aminotransferase (ALT) (<2.5 *ULN); total bilirubin (<1.5 *ULN); serum creatinine (<1.5 *ULN); the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.
Exclusion Criteria:
cockroach or xinmailong allergy (including xinmailong test positive).
Pregnant or lactation woman
severe bleeding tendency;
With mental disease
With severe infection or active gastrointestinal ulcers
allergic to chemotherapeutic agents;
Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ).
With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
taking part or participating in other clinical trials within one month.
previous history of severe cardiovascular disease or cardiovascular disease risk factors were ≥ 4.
Facility Information:
Facility Name
National Cancer Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Ma, MD
Phone
8610-87788495
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
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