Status:
UNKNOWN
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
Lead Sponsor:
Peking Union Medical College
Conditions:
Breast Neoplasms
Cardiac Event
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
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 pacl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03785704
Start Date
January 1 2019
End Date
March 1 2025
Last Update
January 22 2020
Active Locations (1)
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1
National Cancer Center
Beijing, China