NCT02718144

Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer

Completed Phase 1, PHASE2 Last updated 18 June 2021

What this trial tests

Phase 1, PHASE2 trial testing Estetrol in Breast Neoplasms in 12 participants. Completed in 31 December 2019.

Timeline

1 June 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Pantarhei Oncology B.V.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	1 June 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	2 locations across Germany

Drugs / interventions tested

• Estetrol (ESTETROL) — full drug profile →

Conditions studied

• Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Pantarhei Oncology B.V.

Who can join

Eligibility, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3 cohort design to determine the recommended dose of estetrol for the treatment of patients with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of treatment), patients will receive further treatment for 8 weeks at their individual phase I dose level (phase IIa part of the study).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tumor suppression, dose-limiting toxicity and wellbeing with the fetal estrogen estetrol in patients with advanced breast cancer.
   Schmidt M, Lenhard H, Hoenig A, Zimmerman Y, et al · · 2021 · cited 16× · PMID 33242131 · DOI 10.1007/s00432-020-03472-8