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    TROPION-Breast04: a randomized phase III study of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab versus standard of care in patients with treatment-naïve early-stage triple negative or HR-low/HER2− breast cancer by Heather L. McArthur, Sara M. Tolaney, Rebecca Dent, Peter Schmid, Jamil Asselah, Qiang Liu, Jane Lowe Meisel, Naoki Niikura, Yeon Hee Park, Gustavo Werutsky, Giampaolo Bianchini, Jay C. Andersen, Robert Kozarski, Nana Rokutanda, Barbara Pistilli, Sibylle Loibl

    Published 2025-02-01
    “…Design: This is an ongoing, international, phase III, open-label, randomized controlled study. Methods and analysis: Approximately 1728 patients (aged ⩾18 years) will be randomized 1:1 to eight cycles of neoadjuvant Dato-DXd (6 mg/kg intravenously (IV) every 3 weeks (Q3W)) plus durvalumab (1120 mg IV Q3W) followed by nine cycles of adjuvant durvalumab (1120 mg IV Q3W) with or without chemotherapy versus eight cycles of pembrolizumab (200 mg IV Q3W) plus chemotherapy followed by nine cycles of adjuvant pembrolizumab (200 mg IV Q3W) with or without chemotherapy. …”
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    Long-term neuropsychologic outcome of pre-emptive mTOR inhibitor treatment in children with tuberous sclerosis complex (TSC) under 4 months of age (PROTECT), a two-arm, randomized, observer-blind, controlled phase IIb national multicentre clinical trial: study protocol by Jan H. Driedger, Julian Schröter, PROTECT-Study Group, Steffen Syrbe, Afshin Saffari

    Published 2025-01-01
    “…Methods This two-arm, randomized, observer-blind, phase IIb national multicenter clinical trial aims at investigating the long-term neuropsychologic outcomes of pre-emptive mTOR inhibitor treatment in children diagnosed with TSC under four months of age. …”
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    Safety, Tolerability, and Immunogenicity of the Invaplex<sub>AR-Detox</sub> <i>Shigella</i> Vaccine Co-Administered with the dmLT Adjuvant in Dutch and Zambian Adults: Study Protocol for a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase Ia/b Clinical Trial by Geert V. T. Roozen, Nsofwa Sukwa, Masuzyo Chirwa, Jessica A. White, Marcus Estrada, Nicole Maier, Kevin R. Turbyfill, Renee M. Laird, Akamol E. Suvarnapunya, Aicha Sayeh, Flavia D’Alessio, Candice Marion, Laura Pattacini, Marie-Astrid Hoogerwerf, Rajagopal Murugan, Manuela Terrinoni, Jan R. Holmgren, Sodiomon B. Sirima, Sophie Houard, Michelo Simuyandi, Meta Roestenberg

    Published 2025-01-01
    “…Methods: In a multi-center, randomized, double-blind, and placebo-controlled dose-escalation phase Ia/b trial, the safety, tolerability, and immunogenicity of three intramuscular vaccinations administered 4 weeks apart with 2.5 µg or 10 µg of Invaplex<sub>AR-Detox</sub> vaccine, alone or in combination with 0.1 µg of the dmLT adjuvant, will first be assessed in a total of 50 healthy Dutch adults (phase Ia) and subsequently in 35 healthy Zambian adults (phase Ib) aged 18–50 years. …”
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