Using Shengmai San to Prevent Heart Issues from Breast Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of Shengmai San in preventing cardiac toxicity associated with anthracycline sequential trastuzumab therapy in patients with HER2 positive breast cancer. It is a randomized, controlled, open-label study where participants are assigned to either an experimental group receiving Shengmai San or a control group without the treatment. The primary outcome measure is the incidence of cardiac toxicity, assessed through various cardiac function indicators during the treatment process. The study aims to provide insights into the potential protective effects of traditional Chinese medicine in this context.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. 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%
3. Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment；
4. ECOG PS: 0-1 points；
5. 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 Criteria:

1. The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II)
2. Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc
3. 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
4. Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis
5. Unable to cooperate with treatment and follow-up.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ping Huang — Zhejiang Cancer Hospital
• Study coordinator: Ping Huang
• Email: zlyyhp@163.com
• Phone: +8613685766632

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.