drugset / Trial / NCT06214195
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
RandomizedParallel-groupOpen-labelPrevention
Summary
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
Timeline
- Start
- 2024-01-20
- Primary completion
- 2026-12-01
- Completion
- 2030-12-01
Publications
- Background Eiermann W; International Herceptin Study Group. Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: pivotal trial data. Ann Oncol. 2001;12 Suppl 1:S57-62.
- Background Seidman A, Hudis C, Pierri MK, Shak S, Paton V, Ashby M, Murphy M, Stewart SJ, Keefe D. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol. 2002 Mar 1;20(5):1215-21. doi: 10.1200/JCO.2002.20.5.1215.
- Background Farolfi A, Melegari E, Aquilina M, Scarpi E, Ibrahim T, Maltoni R, Sarti S, Cecconetto L, Pietri E, Ferrario C, Fedeli A, Faedi M, Nanni O, Frassineti GL, Amadori D, Rocca A. Trastuzumab-induced cardiotoxicity in early breast cancer patients: a retrospective study of possible risk and protective factors. Heart. 2013 May;99(9):634-9. doi: 10.1136/heartjnl-2012-303151. Epub 2013 Jan 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Shengmai San | Traditional medicine (herbal / TCM) | — | Oral |