The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
Recruiting · NCT06214195 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhejiang Cancer Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)
What this trial is about
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China