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New treatment option for Cardiotoxicity Induced by Drug Therapy for Breast Cancer
Official title The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
ClinicalTrials.gov ID: NCT06214195
What this study is testing
What is Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)?
Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis) is an investigational medicine, given as a twice-daily, being studied as a potential treatment for cardiotoxicity induced by drug therapy for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Non metastatic primary invasive HER2 positive breast cancer stage I-III invasive HER2 positive breast cancer is defined as the tumor invasive...
- Plan to use AC sequential TH (P) adjuvant or neoadjuvant chemotherapy with anthracycline containing chemotherapy regimens (A is doxorubicin or...
- 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...
You likely can't join 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...
- Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis
- Unable to cooperate with treatment and follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.