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(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

Ensayo de ATOSSA THERAPEUTICS, INC. en Neoplasias de mama · Cancer de mama invasivo · Cancer de mama con receptor de estrogeno positivo · Cancer de mama HER2 negativo.

Más ensayos de: Cáncer de mama · Cáncer de mama HER2 negativo.

Fase: Fase 2
Estado: En marcha, sin reclutar
Participantes: 87
Centros: 14
Fin del objetivo primario: nov 2026

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2023.

Qué mide

Cohorte de PK - Concentraciones plasmaticas en estado estacionario de (Z)-endoxifeno (After 4 weeks of treatment) (del registro, en inglés)

Qué se prueba

El estudio examina (Z)-endoxifen como posible tratamiento en mujeres premenopáusicas con cáncer de mama ER+/HER2-.

Lo que dice el documentoThis open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells.

Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part. The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it. The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%. A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery. Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Más ensayos de ATOS

Ensayo	Fase	Estado	Lectura de resultados
Z-Endoxifen	Fase 2	Completado	jun 2024 (real)
AT-301B	Fase 1	Completado	dic 2020 (real)
Fulvestrant · 007	Fase 2	Interrumpido	ago 2020 (real)
Topical endoxifen · CREME	Fase 2	Completado	sep 2018 (real)
ForeCYTE Breast Aspirator	Fase 3	Retirado antes de empezar	dic 2015 (prevista, ya pasada: sin actualizar en el registro)
ForeCYTE Breast Aspirator	no aplica	Completado	ago 2014 (real)

Todos los de ATOS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05607004), actualizada en jul 2026.