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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.

ClinicalTrials.gov IDNCT06214195
PhasePHASE3
Enrollment276
SponsorZhejiang Cancer Hospital
Age18 Years
SexALL
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Conditions studied

Cardiotoxicity Induced by Drug Therapy for Breast Cancer

About this study

To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: 1. 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 2. 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% 3. Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment; 4. ECOG PS: 0-1 points; 5. 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: 1. The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II) 2. Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc 3. 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 4. Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis 5. Unable to cooperate with treatment and follow-up.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.