Clinical Trial

PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin

Study acronym: SABINA

Active, Not Recruiting Phase 2

Record status

This record was last updated March 10, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Summary

The multicenter, two-cohort, non-comparative, open-label, phase II clinical trial SABINA aims to analyze the safety and efficacy of MEN1611 in monotherapy and in combination with eribulin, a non-taxane chemotherapy agent, in Hormone Receptor (HR)-known/Human Epidermial Growth Factor Receptor 2 (HER2)-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/ Phosphatase and Tensin Homolog (PTEN)-altered, unresectable locally advanced or metastatic metaplastic breast carcinoma (MpBC) patients. A run-in phase for safety and tolerability of MEN1611 in combination with standard doses of eribulin will be conducted as an initial step of the cohort A. This first step aims at evaluating the dosing schedule of MEN1611, by analyzing the toxicity profile of the combined regimen. With the background of the first-in-human study (PA-001EU), the safe dose of MEN1611 has been established as 48 mg orally BID (two intakes of 3 capsules of 16 mg each, for a total daily dose of 96 mg MEN1611 free-base).

Protocol Amendment History 17 amendments

This ClinicalTrials.gov record has been amended 17 times since 2023-04-11; most recent amendment 2026-03-06.

Status change: Recruiting → Active, Not Recruiting 2026-03-06

Status change: Not Yet Recruiting → Recruiting 2023-05-26

Trial Details

NCT Number	NCT05810870
Lead Sponsor	MedSIR Collaborators: Menarini Group
Conditions	Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
Enrollment	14 participants
Start Date	2023-05-24
Primary Completion	2026-04 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-03-10