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: Completed

Phase of Trial: Phase I

Latest Information Update: 01 Jul 2025

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At a glance

Drugs MEN 1611 (Primary) ; Trastuzumab (Primary) ; Fulvestrant
Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
Focus Adverse reactions
Acronyms B-PRECISE-01
Sponsors Menarini Ricerche

15 May 2024 Status changed from active, no longer recruiting to completed.
23 May 2023 Planned End Date changed from 31 Jul 2022 to 21 Dec 2023.
23 May 2023 Planned primary completion date changed from 31 Jul 2022 to 21 Dec 2023.

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