Cardiotoxicity Induced by Drug Therapy for Breast CancerPhase 3STARTNCT06214195
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
A Phase 3 study testing Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis) in people with Cardiotoxicity Induced by Drug Therapy for Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity Induced by Drug Therapy for Breast Cancer
- What is being tested?
- Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 1 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Non metastatic primary invasive HER2 positive breast cancer stage I-III invasive HER2 positive breast cancer is defined as the tumor invasive component HER2 immunohistochemical IHC+++or IHC++confirmed to be HER2 positive by fluorescence in situ hybridization
- Plan to use AC sequential TH (P) adjuvant or neoadjuvant chemotherapy with anthracycline containing chemotherapy regimens (A is doxorubicin or epirubicin, C is cyclophosphamide, T is paclitaxel, liposome paclitaxel, albumin bound paclitaxel or docetaxel, H is trastuzumab, which can be combined with pertuzumab (P))，and before using anthracycline drugs, the left ventricular ejection fraction (LVEF) should be ≥ 50%
- Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment；
- ECOG PS: 0-1 points；
- The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study, and sign a written informed consent form.
Who cannot join
- The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II)
- Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc
- There are contraindications or intolerance to treatment with trastuzumab, including allergies to trastuzumab, and the presence of underlying heart diseases that cannot be treated with trastuzumab as determined by a specialist
- Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis
- Unable to cooperate with treatment and follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ping Huang, +86-13685766632, zlyyhp@163.com
Zhanhong Chen, +86-13606505124, czred@sina.com
About this study
Official title: Clinical Study on the Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
Read the detailed description
This study is a randomized, controlled, open-label prospective clinical study. This study adopts an optimal design, with the main evaluation indicator being the incidence of cardiac toxicity. Patients who passed the inclusion and exclusion criteria through clinical research were randomly assigned to the experimental group and control group. Experimental(treatment)group: received preventive treatment with Shengmai Powder，and may also receive additional Chinese medicines based on the doctor's judgment and the patient's condition.Control group: during chemotherapy and trastuzumab administration, no Chinese medicine with ginseng, ophiopogon japonicus and schisandra chinensis as ingredients or western medicine with heart strengthening or heart protection function were used. During the treatment process, cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) are evaluated to determine the occurrence of cardiac toxicity.
- Being tested
- Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)
- Keywords
- prevent, cardiotoxicity, trastuzumab, chemotherapy, anthracycline
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)Drug
Ginseng 6g , Ophiopogon japonicus 12g ,Schisandra chinensis 5g , other secondary Chinese medicines can be added according to the doctor's judgment and the patient's condition，decoction in water, one dose and two decoctions, taken twice a day, continuously for 7 days from the start of each chemotherapy cycle (± 3 days), including anthracyclines and taxanes (the frequency and dosage of medication can be adjusted according to adverse reactions in the later stage); The total duration of medication interventionis 7 days per cycle, with a total of 8 cycles. If the chemotherapy is less than 8 cycles, continue taking for 7 consecutive days from the start of each subsequent trastuzumab cycle (the frequency and dosage can be adjusted based on adverse reactions) until a total of 8 cycles are reached.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Provide preventive treatment with Shengmai San Receives: Drug: Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis) |
| control group | No intervention | No preventive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cardiotoxicity in the treatment group and control group
Calculate the incidence of cardiotoxicity associated with anthracycline sequential trastuzumab treatment of two groups.Cardiotoxicity is defined as the occurrence of symptomatic congestive heart failure, or a decrease in left ventricular ejection fraction (LVEF) without clinical symptoms that meets one of the following conditions: ① a decrease of ≥ 15% in LVEF from baseline after anti-cancer treatment; ② After anti-cancer treatment, LVEF decreased by ≥ 10% from baseline and the monitoring value was<50%; ③ LVEF monitoring value after anti-cancer treatment is less than 45%. The definition of symptomatic congestive heart failure includes but is not limited to any one or more of the following: moist rales in the lungs, anterior tibial edema in both lower limbs, and cyanosis of the lips.
Measured: From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment.
Secondary outcomes (1)
The incidence of adverse events in the treatment group and control group, except for cardiotoxicity
Using the Common Terminology Criteria for Adverse Events (CTC AE) version 5.0, evaluate the adverse events and toxic reactions of the two groups, except for cardiotoxicity, to determine the incidence rate.
Measured: From the use of anthracycline drugs or Shengmai San to 1.5 years after the start of trastuzumab treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiotoxicity Induced by Drug Therapy for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The risk exposure factors for the experimental group and the control group are the same
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Ping, Zhejiang Cancer Hospital
- Investigators
- Ping Huang, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214195
- Sponsor's protocol ID
- ZCHBC025
- Acronym
- START
- Status last verified
- Jan 2024
- First submitted
- 25 Nov 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can apply to researchers
Publications
Eiermann W; International Herceptin Study Group. Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: pivotal trial data. Ann Oncol. 2001;12 Suppl 1:S57-62.
PubMed 11521723Seidman A, Hudis C, Pierri MK, Shak S, Paton V, Ashby M, Murphy M, Stewart SJ, Keefe D. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol. 2002 Mar 1;20(5):1215-21. doi: 10.1200/JCO.2002.20.5.1215.
PubMed 11870163Farolfi A, Melegari E, Aquilina M, Scarpi E, Ibrahim T, Maltoni R, Sarti S, Cecconetto L, Pietri E, Ferrario C, Fedeli A, Faedi M, Nanni O, Frassineti GL, Amadori D, Rocca A. Trastuzumab-induced cardiotoxicity in early breast cancer patients: a retrospective study of possible risk and protective factors. Heart. 2013 May;99(9):634-9. doi: 10.1136/heartjnl-2012-303151. Epub 2013 Jan 24.
PubMed 23349345
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
- ClinicalTrials.gov ID
- NCT06214195
- Acronym / sponsor ID
- START / ZCHBC025
- Keywords
- prevent, cardiotoxicity, trastuzumab, chemotherapy, anthracycline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 19 Jan 2024 (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.
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
Detailed description
This study is a randomized, controlled, open-label prospective clinical study. This study adopts an optimal design, with the main evaluation indicator being the incidence of cardiac toxicity. Patients who passed the inclusion and exclusion criteria through clinical research were randomly assigned to the experimental group and control group. Experimental(treatment)group: received preventive treatment with Shengmai Powder，and may also receive additional Chinese medicines based on the doctor's judgment and the patient's condition.Control group: during chemotherapy and trastuzumab administration, no Chinese medicine with ginseng, ophiopogon japonicus and schisandra chinensis as ingredients or western medicine with heart strengthening or heart protection function were used. During the treatment process, cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) are evaluated to determine the occurrence of cardiac toxicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The risk exposure factors for the experimental group and the control group are the same
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)Provide preventive treatment with Shengmai San |
| control group | No intervention | –No preventive intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non metastatic primary invasive HER2 positive breast cancer stage I-III invasive HER2 positive breast cancer is defined as the tumor invasive component HER2 immunohistochemical IHC+++or IHC++confirmed to be HER2 positive by fluorescence in situ hybridization
- Plan to use AC sequential TH (P) adjuvant or neoadjuvant chemotherapy with anthracycline containing chemotherapy regimens (A is doxorubicin or epirubicin, C is cyclophosphamide, T is paclitaxel, liposome paclitaxel, albumin bound paclitaxel or docetaxel, H is trastuzumab, which can be combined with pertuzumab (P))，and before using anthracycline drugs, the left ventricular ejection fraction (LVEF) should be ≥ 50%
- Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment；
- ECOG PS: 0-1 points；
- The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study, and sign a written informed consent form.
Key exclusion criteria (5 listed)
- The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II)
- Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc
- There are contraindications or intolerance to treatment with trastuzumab, including allergies to trastuzumab, and the presence of underlying heart diseases that cannot be treated with trastuzumab as determined by a specialist
- Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis
- Unable to cooperate with treatment and follow-up.
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 |
|---|---|---|
| Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)Ginseng 6g , Ophiopogon japonicus 12g ,Schisandra chinensis 5g , other secondary Chinese medicines can be added according to the doctor's judgment and the patient's condition，decoction in water, one dose and two decoctions, taken twice a day, continuously for 7 days from the start of each chemotherapy cycle (± 3 days), including anthracyclines and taxanes (the frequency and dosage of medication can be adjusted according to adverse reactions in the later stage); The total duration of medication interventionis 7 days per cycle, with a total of 8 cycles. If the chemotherapy is less than 8 cycles, continue taking for 7 consecutive days from the start of each subsequent trastuzumab cycle (the frequency and dosage can be adjusted based on adverse reactions) until a total of 8 cycles are reached. | Drug | treatment group |
Primary outcome
The incidence of cardiotoxicity in the treatment group and control group
Time frame: From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment.
Calculate the incidence of cardiotoxicity associated with anthracycline sequential trastuzumab treatment of two groups.Cardiotoxicity is defined as the occurrence of symptomatic congestive heart failure, or a decrease in left ventricular ejection fraction (LVEF) without clinical symptoms that meets one of the following conditions: ① a decrease of ≥ 15% in LVEF from baseline after anti-cancer treatment; ② After anti-cancer treatment, LVEF decreased by ≥ 10% from baseline and the monitoring value was<50%; ③ LVEF monitoring value after anti-cancer treatment is less than 45%. The definition of symptomatic congestive heart failure includes but is not limited to any one or more of the following: moist rales in the lungs, anterior tibial edema in both lower limbs, and cyanosis of the lips.
1 secondary outcome
The incidence of adverse events in the treatment group and control group, except for cardiotoxicity
Time frame: From the use of anthracycline drugs or Shengmai San to 1.5 years after the start of trastuzumab treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 11521723Eiermann W; International Herceptin Study Group. Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: pivotal trial data. Ann Oncol. 2001;12 Suppl 1:S57-62.
- Background: PubMed 11870163Seidman A, Hudis C, Pierri MK, Shak S, Paton V, Ashby M, Murphy M, Stewart SJ, Keefe D. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol. 2002 Mar 1;20(5):1215-21. doi: 10.1200/JCO.2002.20.5.1215.
- Background: PubMed 23349345Farolfi A, Melegari E, Aquilina M, Scarpi E, Ibrahim T, Maltoni R, Sarti S, Cecconetto L, Pietri E, Ferrario C, Fedeli A, Faedi M, Nanni O, Frassineti GL, Amadori D, Rocca A. Trastuzumab-induced cardiotoxicity in early breast cancer patients: a retrospective study of possible risk and protective factors. Heart. 2013 May;99(9):634-9. doi: 10.1136/heartjnl-2012-303151. Epub 2013 Jan 24.
- Individual participant dataSharing planned: No. Can apply to researchers
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.
Ping Huang principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis) in people with Cardiotoxicity Induced by Drug Therapy for Breast Cancer, run by Zhejiang Cancer Hospital 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Jan 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ping Huang (+8613685766632, zlyyhp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cardiotoxicity in the treatment group and control group (time frame: From 1 week before enrollment to 1.5 years after the start of trastuzumab treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214195, which also lists 3 linked publications.
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 19 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.