PHASE II STUDY FOR PATIENTS WITH ADVANCED TRIPLE NEGATIVE OR METAPLASTIC HRPOSITIVE/HER2-NEGATIVE, PIK3CA/PTEN-ALTERED BREAST CANCER TREATED WITH ERIBULIN IN COMBINATION WITH MEN1611 -THE SABINA STUDY-

Phase 2

Recruiting

• Conditions: Locally advanced or unresectable PIK3CA and/or PTENaltered metaplastic or non-metaplastic triple negative breast cancer.; Locally advanced or unresectable PIK3CA and/or PTENaltered metaplastic HR-positive/HER2-negative breast cancer

• Registration Number: 2024-512963-30-00
• Lead Sponsor: Medica Scientia Innovation Research S.L.

Brief Summary

To assess the efficacy of MEN1611 in combination with eribulin as

determined by the clinical benefit rate (CBR) in:

1.Locally advanced or unresectable PIK3CA and/or PTENaltered metaplastic or non metaplastic triple negative breast

cancer.

2. Locally advanced or unresectable PIK3CA and/or PTENaltered metaplastic HR-positive/HER2-negative breast

cancer.

Detailed Description

This is a multicenter, two-cohort, non-comparative, open-label, phase II clinical trial to assess:

* the efficacy of MEN1611 in combination with eribulin as determined by the clinical benefit rate (CBR) in unresectable locally advanced or metastatic HR-known/HER2-negative, PIK3CA/ PTEN-altered MpBC patients (Cohort A), and

* the efficacy of MEN1611 as monotherapy as determined by the objective response rate (ORR) at 6 weeks in unresectable locally advanced or metastatic HR-known/HER2-negative, PIK3CA/ PTEN-altered MpBC patients (Cohort B).

Upon meeting all selection criteria, 28 patients will be enrolled as follows:

\- Cohort A: A run-in phase for safety and tolerability of MEN1611 in combination with eribulin will be conducted in this patient population (N=3). A Steering Committee decision/agreement is needed, after reviewing all toxicities, to expand this cohort with 11 additional patients (up to N=14).

Cohort B will be run only if positive finding in Cohort A, defined as ≥ 6 patients (42.9%) with achieved clinical benefit (CB) among 14 first recruited patients.

\- Cohort B: Simon's two-stage minimax design. Stage I (N=7) will be initiated with MEN1611 monotherapy. This cohort will be stopped for futility if no responders (no complete response \[CR\] or partial response \[PR\]) are observed after 2 cycles among the first 7 patients included. Otherwise, Cohort B will be expanded with 7 additional patients for Stage II (up to N=14).

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-12
• Study Start: 2023-05-24
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-04
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CBR, defined as the percentage of patients who experience a complete response (CR), partial response (PR) or stable disease (SD) for at least 12 weeks after the start of treatment (MEN1611 in combination with eribulin), as determined locally by the Investigator per RECIST v1.1 criteria.		CBR, defined as the percentage of patients who experience a complete response (CR), partial response (PR) or stable disease (SD) for at least 12 weeks after the start of treatment (MEN1611 in combination with eribulin), as determined locally by the Investigator per RECIST v1.1 criteria.

Secondary Outcome Measures

Name	Time	Method
SECONDARY ENDPOINT: To assess the efficacy of MEN1611 in combination with eribulin as determined locally by the investigator as per RECIST v1.1 criteria by:		SECONDARY ENDPOINT: To assess the efficacy of MEN1611 in combination with eribulin as determined locally by the investigator as per RECIST v1.1 criteria by:
ORR defined as the proportion of patients with confirmed CR or PR.		ORR defined as the proportion of patients with confirmed CR or PR.
TTR defined as the time from the start of treatment to the first objective tumor response (tumor shrinkage of ≥ 30%).		TTR defined as the time from the start of treatment to the first objective tumor response (tumor shrinkage of ≥ 30%).
DoR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.		DoR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.
PFS defined as the time from the first dose of Study drugs until objective tumor progression or death, whichever occurs first.		PFS defined as the time from the first dose of Study drugs until objective tumor progression or death, whichever occurs first.
OS defined as the time from the first dose of Study drugs until death from any cause.		OS defined as the time from the first dose of Study drugs until death from any cause.
SECONDARY ENDPOINT: To evaluate the incidence of adverse events (AEs) as assessed by the investigator, with severity determined by NCI-CTCAE v.5.0 of MEN1611 in combination with eribulin.		SECONDARY ENDPOINT: To evaluate the incidence of adverse events (AEs) as assessed by the investigator, with severity determined by NCI-CTCAE v.5.0 of MEN1611 in combination with eribulin.

Trial Locations

Locations (13)

Hospital Universitario Clínico San Cecilio de Granada; 🇪🇸 Granada, Andalusia, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Seville, Andalusia, Spain

Onkologikoa; 🇪🇸 Donostia / San Sebastian, Basque Country, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Centro Oncológico de Galicia; 🇪🇸 A Coruña, Galicia, Spain

Hospital Universitario de Torrejón; 🇪🇸 Torrejón de Ardoz, Madrid, Spain

CHUVI - Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Institut Català d' Oncologia L'Hospitalet (ICO); 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

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