drugset / Trial / NCT06439693

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

NCT06439693

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants. The names of the study drugs involved in this study are: * Paclitaxel (a type of anti-microtubule agent) * Docetaxel (a type of anti-microtubule agent) * Nab-Paclitaxel (a type of anti-microtubule agent) * Trastuzumab (a type of IgG1 kappa monoclonal antibody) * Pertuzumab (a type of monoclonal antibody) * Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate) * Tucatinib (Tyrosine Kinase HER2 Inhibitor) * Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

Timeline

Start
2024-08-08
Primary completion
2030-03-30
Completion
2033-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Pertuzumab Monoclonal antibody 20 ml Intravenous
Subject Phesgo Unknown 10 ml Subcutaneous
Subject Phesgo Unknown 15 ml Subcutaneous
Subject Trastuzumab Monoclonal antibody 6 ml Subcutaneous
Subject Trastuzumab Monoclonal antibody 150 mg Subcutaneous
Subject Trastuzumab deruxtecan Monoclonal antibody 100 mg Intravenous
Subject Trastuzumab emtansine Other / unclassified 16 mg Intravenous
Subject Trastuzumab emtansine Other / unclassified 100 mg Intravenous
Subject Tucatinib Small molecule 50 mg Oral
Subject Tucatinib Small molecule 150 mg Oral