Actively Recruiting
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
Led by Zhejiang Cancer Hospital · Updated on 2024-01-19
276
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with non-metastatic primary invasive HER2-positive breast cancer stage I-III confirmed by immunohistochemistry or fluorescence in situ hybridization
- Planned treatment with anthracycline-containing chemotherapy followed by trastuzumab or trastuzumab combined with pertuzumab for one year
- Left ventricular ejection fraction (LVEF) at or above 50% before starting anthracycline drugs
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 points
- Ability to comply with treatment and follow-up, understand the study, and provide written informed consent
You will not qualify if you...
- Heart disease classified as New York Heart Association (NYHA) class II or above
- Severe heart disease or high-risk uncontrolled arrhythmia
- Contraindications or intolerance to trastuzumab, including allergies or untreatable underlying heart disease
- Allergic to ginseng, Ophiopogon japonicus, or Schisandra chinensis
- Unable to cooperate with treatment and follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
P
Ping Huang
CONTACT
Z
Zhanhong Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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