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Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

Trial Profile

Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Oct 2019

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At a glance

  • Drugs MEN 1611 (Primary) ; Trastuzumab (Primary) ; Fulvestrant
  • Indications Adenocarcinoma; Advanced breast cancer
  • Focus Adverse reactions
  • Acronyms B-PRECISE-01
  • Sponsors Menarini Ricerche
  • Most Recent Events

    • 04 Jun 2019 Trial design presented at the 55th Annual Meeting of the American Society of Clinical Oncology
    • 23 May 2019 According to a Menarini media release, design of this study will be presented at the ASCO Annual Meeting 2019.
    • 26 Oct 2018 New trial record
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