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

StatusRecruiting
PhasePhase 2
Started2024-08-08
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
minor
Study Status v3
Re-verified, no change to tracked fields
2025-06-23
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2025-04-01
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11→confirmed 2024-08-08
Study sitesdetails revised at 1 of 1 site
Study title-32 characters
The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
2024-05-28
minor
Original filing
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)
Trial Details
NCT Number NCT06439693
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Translational Breast Cancer Research Consortium, Johns Hopkins University
Conditions Breast Cancer Female, Breast Cancer, Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Stage IV Breast Cancer
Enrollment 72 participants
Start Date 2024-08-08
Primary Completion 2030-03-30 (estimated)
Study Completion 2033-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06