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A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breast Cancer and Ribociclib, Trastuzumab, and Tucatinib Versus Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in Patients With HR-/HER2+ Breast Cancer

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Trial Profile

A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breast Cancer and Ribociclib, Trastuzumab, and Tucatinib Versus Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in Patients With HR-/HER2+ Breast Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Apr 2024

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At a glance

  • Drugs Fulvestrant (Primary) ; Ribociclib (Primary) ; Trastuzumab (Primary) ; Tucatinib (Primary) ; Carboplatin; Docetaxel; Pertuzumab
  • Indications Advanced breast cancer; Carcinoma; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 17 Apr 2024 Planned End Date changed from 1 Apr 2025 to 1 Apr 2026.
    • 17 Apr 2024 Planned primary completion date changed from 1 Apr 2024 to 1 Apr 2025.
    • 06 Jun 2023 As of Jan 2023, 1 participant has been enrolled in dose level 1, according to Trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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