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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xinmailong injection group | Experimental | 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. |
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| control group | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xinmailong Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
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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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000618382 | xinmailong |
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Totally 60 subjects will be included in the study.Random assignment was 1:1 to Xinmailong injection group and control group.
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|
| D017437 |
| Skin and Connective Tissue Diseases |