The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |