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

Phase 2

Recruiting

• Conditions: Cardiac Event; Chemotherapeutic Toxicity; Breast Neoplasms
• Interventions: Drug: Xinmailong Injection

• Registration Number: NCT03785704
• Lead Sponsor: Peking Union Medical College

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.

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-01-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-22
• Primary Completion: 2020-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xinmailong injection group	Xinmailong Injection	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.

Primary Outcome Measures

Name	Time	Method
The rate of no cardiac events during chemotherapy	up to 12 months	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

Name	Time	Method
Disease-free survival (DFS)	5 years	The time between the start of a randomized clinical trial and the onset of disease recurrence or death from any cause

Trial Locations

Locations (1)

National Cancer Center; 🇨🇳 Beijing, China