Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06214195

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here