Using Shengmai San to Prevent Heart Issues from Breast Cancer Treatment
Clinical Study on the Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
This study is testing whether a traditional Chinese medicine called Shengmai San can help prevent heart problems in people with HER2 positive breast cancer who are receiving certain chemotherapy treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06214195 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with non-metastatic HER2 positive breast cancer who are planning to undergo anthracycline sequential trastuzumab therapy.
Not a fit: Patients with metastatic breast cancer or those not eligible for anthracycline therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of cardiac toxicity in patients undergoing breast cancer treatment.
How similar studies have performed: While the use of traditional Chinese medicine in cancer care is gaining interest, this specific approach to preventing cardiac toxicity during trastuzumab therapy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.