Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College

Criteria

Inclusion Criteria:

1. age ≥18 years, female;

2. after radical mastectomy, EC - T adjuvant chemotherapy is planned.

3. No relevant treatment (such as antineoplastic therapy, immunotherapy, etc.) that may affect the outcome of treatment was received before admission.

4. ECOG PS score: 0-2 points;

5. 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:

1. cockroach or xinmailong allergy (including xinmailong test positive).

2. Pregnant or lactation woman

3. severe bleeding tendency;

4. With mental disease

5. With severe infection or active gastrointestinal ulcers

6. allergic to chemotherapeutic agents;

7. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ).

8. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes

9. taking part or participating in other clinical trials within one month.

10. previous history of severe cardiovascular disease or cardiovascular disease risk factors were ≥ 4.