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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms; Chemotherapeutic Toxicity; Cardiac Event
• Intervention / Treatment: Drug: Xinmailong Injection

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • National Cancer Center
    • Contact: Fei Ma, MD; Phone Number: 8610-87788495

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xinmailong injection group; 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.	Drug: Xinmailong Injection; 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.
No Intervention: control group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Xinmailong injection; anthracycline induced cardiac toxicity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC1786

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No