Breast NeoplasmsPhase 2NCT03785704
Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
A Phase 2 study testing Xinmailong Injection in people with Breast Neoplasms and Cardiac Event, run by Peking Union Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Cardiac Event, Chemotherapeutic Toxicity
- What is being tested?
- Xinmailong Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center
Beijing
Fei Ma, MD, 8610-87788495
About this study
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.
Read the 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.
- Conditions
- Breast Neoplasms, Cardiac Event, Chemotherapeutic Toxicity
- Being tested
- Xinmailong Injection
- Keywords
- Xinmailong injection, anthracycline induced cardiac toxicity
- Medical subject headings
- Breast Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xinmailong InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Xinmailong injection group | Experimental | 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. Receives: Drug: Xinmailong Injection |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Totally 60 subjects will be included in the study.Random assignment was 1:1 to Xinmailong injection group and control group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Ma, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785704
- Sponsor's protocol ID
- NCC1786
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT03785704
- Acronym / sponsor ID
- NCC1786
- Conditions
- Breast Neoplasms, Cardiac Event, Chemotherapeutic Toxicity
- Keywords
- Xinmailong injection, anthracycline induced cardiac toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Totally 60 subjects will be included in the study.Random assignment was 1:1 to Xinmailong injection group and control group.
| Arm | Type | Receives |
|---|---|---|
| Xinmailong injection group | Experimental | Drug: Xinmailong Injectiongiven 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. |
| control group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xinmailong InjectionXinmailong 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. | Drug | Xinmailong injection group |
Primary outcome
The rate of no cardiac events during chemotherapy
Time frame: 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.
1 secondary outcome
Disease-free survival (DFS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xinmailong Injection in people with Breast Neoplasms and Cardiac Event, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of no cardiac events during chemotherapy (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.