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 Nab-paclitaxel 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