Clinical trial · Interventional
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
NCT03785704CI-TRIAL-00042910unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cardiac Event | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Xinmailong Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Xinmailong injection group
- 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.
- interventionNames
- Drug: Xinmailong Injection
- type
- NO_INTERVENTION
- label
- control group
- 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).
Primary outcomes (1)
- measure
- The rate of no cardiac events during chemotherapy
- timeFrame
- up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.