The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
Recruiting now · Phase 3
Conditions studied: Cardiotoxicity Induced by Drug Therapy for Breast Cancer
In brief
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
Key facts
- Study ID
- NCT06214195
- Run by
- Zhejiang Cancer Hospital
- People needed
- 276
- Starts
- 2024-01-20
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2024-01-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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