A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination With Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 20 Mar 2025

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At a glance

Drugs Abemaciclib (Primary) ; Copanlisib (Primary) ; Fulvestrant (Primary)
Indications Advanced breast cancer; Carcinoma; HER2 negative breast cancer; Male breast cancer
Focus Adverse reactions
Acronyms FAC vs FA

Most Recent Events

17 Mar 2025 Status changed from active, no longer recruiting to completed.
04 Feb 2025 Primary efficacy end-point "Progression-free survival (PFS) (Phase II)" has been removed and added to secondary end-points, thus making "AR" the only trial focus.
10 Dec 2024 The protocol has been amended to change in treatment arm size and phase change.

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