Status:
RECRUITING
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Cardiotoxicity Induced by Drug Therapy for Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06214195
Start Date
January 20 2024
End Date
December 1 2030
Last Update
January 19 2024
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022