Trial Profile

The global Phase 2, multi-center dose-ranging study of endoxifen monotherapy for safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity in women with metastatic breast cancer

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 12 Jan 2026

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At a glance

Drugs Endoxifen (Primary)
Indications Advanced breast cancer
Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use

06 Jan 2026 According to Atossa Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) issued a Study May Proceed letter for the Companys study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen.
17 Oct 2025 New trial record
20 Aug 2025 According to Atossa Therapeutics media release, the study was designed following guidance from the U.S. Food and Drug Administration (FDA) and is intended to directly inform a subsequent Phase 3 trial.

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