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Breast CancerPhase 2SABINANCT05810870

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

A Phase 2 study testing MEN1611 and Eribulin in people with Breast Cancer and Advanced Breast Cancer, run by MedSIR at 13 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MEN1611 and Eribulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
13 sitesSpain
Study dates
24 May 2023to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Any patient meeting ANY of the following criteria will be excluded from the Study:
  • Current participation in another therapeutic clinical trial.
  • Extra-cranial radiotherapy or limited-field palliative radiotherapy within 7 days prior to Study enrolment, or patients who have not recovered from radiotherapy-related toxicities to baseline or grade ≤ 1 and/or from whom ≥ 25% of the bone marrow has been previously irradiated.
  • Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 21 days of start of Study drug, or patients who have not recovered from the side effects of any major surgery.
  • Patient with a concurrent malignancy or malignancy within 5 years of Study enrollment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer.
  • Note: For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
Show all 30Show fewer
  • Treatment with approved chemotherapy/immunotherapy/ targeted agents within 21 days prior to initiation of Study, or treatment with an investigational cancer therapy for 21 days or 5 half-lives (whichever is longer) prior to initiation of any Study treatment.
  • Patient with cerebrovascular accident or transient ischemic attack within 6 months prior to the start of any Study treatment.
  • Congenital long QT syndrome or screening QT interval corrected using Fridericia's formula (QTcF) > 480 milliseconds.
  • Patient with an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including any of the following:
  • Unstable angina pectoris or documented myocardial infarction within 6 months prior to Study entry.
  • Symptomatic pericarditis.
  • Documented congestive heart failure (New York Heart Association functional classification III- IV).
  • Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
  • Ventricular arrhythmias except for benign premature ventricular contractions.
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.
  • Conduction abnormality requiring a pacemaker.
  • Other cardiac arrhythmia not controlled with medication.
  • Patient with uncontrolled hypertension.
  • Uncontrolled diabetes mellitus (glycated haemoglobin [HbA1c] >7%) and/or fasting plasma glucose (FPG) >120 mg/dL or 6.7 mmol/L.
  • Note: Patients who have diabetes mellitus adequately managed regardless FPG or HbA1c may be considered eligible as per the Medical Monitor assessment and criteria.
  • Known concurrent severe and/or uncontrolled concomitant medical conditions (i.e. influenza or any other active infections) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Known active or uncontrolled pulmonary dysfunction.
  • Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
  • Patient with serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with subject safety.
  • History of significant gastrointestinal disease, including but not limited to abdominal fistula, gastrointestinal perforation or other malabsorption syndromes that would impact on drug absorption. Grade ≥2 diarrhea should resolve at least 7 days prior to the start of any Study treatment.
  • Subject receiving chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent.
  • Subject receiving treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A as well as moderate or strong inducers of CYP1A2 within 2 weeks of the first administration of MEN1611.
  • Breastfeeding or pregnancy as determined by a serum pregnancy test (β-HCG) at screening, prior to the administration of MEN1611 in combination with eribulin. Since β-HCG over expression can be also elevated in some tumor types, a positive result should be confirmed with a validated alternative test (e.g., ultrasound).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Centro Oncológico de Galicia

    A Coruña, Galicia, 15009

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Institut Català d' Oncologia L'Hospitalet (ICO)

    Barcelona, 08907

  • Hospital Universitari Vall D'Hebron

    Barcelona

  • Onkologikoa

    Donostia / San Sebastian, Basque Country, 20014

  • Hospital Universitario Clínico San Cecilio de Granada

    Granada, Andalusia, 18016

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Beata María Ana

    Madrid

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Madrid, 28850

  • Instituto Valenciano de Oncología (IVO)

    Valencia, 46009

  • CHUVI - Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36312

Other trials in Spain

About this study

Official title: Phase II Study for Patients With Advanced Triple Negative or Metaplastic HR-positive/HER2-negative, PIK3CA/PTEN-altered Breast Cancer Treated With Eribulin in Combination With MEN1611

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).

Read the 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).
Being tested
MEN1611, Eribulin
Keywords
Breast cancer, MEN1611, Eribulin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEN1611Drug

    MEN1611 is a potent, orally bioavailable selective inhibitor of the class I phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) with a novel structure which exhibits a strong inhibitory activity especially against the PI3K catalytic subunit alpha (PIK3CA), with potential antineoplastic activity. PI3K alpha inhibitor MEN1611 selectively binds to and inhibits PIK3CA and its mutated forms in the PI3K/Akt (protein kinase B)/mammalian target of rapamycin (mTOR) pathway.

  • EribulinDrug

    Also called HALAVEN, Eribulin mesylate

    Eribulin mesylate (eribulin), a non-taxane inhibitor of microtubule dynamics of the halichondrin class of antineoplastics, suppresses microtubule growth and sequesters tubulin into nonfunctional aggregates, preventing mitotic spindle formation with subsequent G2-M stop and apoptosis.

Study groups in NCT05810870
Study groupRoleWhat they receive
Cohort AExperimentalMEN1611 orally (PO) 48 mg twice daily (BID) (2 intakes of 3x16 mg capsules, for a total daily dose of 96 mg MEN1611 free-base) during each 21-day cycle combined with eribulin mesylate 1.4 mg/m2 (equivalent to eribulin 1.23 mg/m2 when expressed as a free base) administered intravenously (IV) over 2 to 5 minutes on days 1 and 8 of every 21-day cycle (CXD1 and CXD8). A run-in phase for safety and tolerability of MEN1611 in combination with eribulin will be conducted after the first 2 cycles on the first 3 patients. Upon Steering Committee agreement the cohort A will be expanded up to N=14 (11 additional patients). Patients will receive treatment until disease progression, unacceptable toxicity, death, discontinuation from the study treatment for any other reason, withdrawal of consent, or study termination.
Receives: Drug: MEN1611; Drug: Eribulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the efficacy of MEN1611 in combination with eribulin as determined by the clinical benefit rate (CBR).

    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 MEN1611 in combination with eribulin treatment, as determined locally by the investigator per RECIST v1.1 criteria.

    Measured: Baseline up to at least 12 weeks

Secondary outcomes (6)

  1. To determine the efficacy of MEN1611 in combination with eribulin defined as ORR of patients.

    ORR, defined as the proportion of patients with confirmed CR or PR who received MEN1611 in combination with eribulin treatment as determined locally by the Investigator as per RECIST v1.1 criteria.

    Measured: Baseline up to 24 months

  2. To determine the efficacy of MEN1611 in combination with eribulin defined as Time To Response (TTR).

    TTR, defined as the time from the start of MEN1611 in combination with eribulin treatment to the first objective tumor response (tumor shrinkage of ≥ 30%).

    Measured: Baseline up to 24 months

  3. To determine the efficacy of MEN1611 in combination with eribulin defined as Duration of Response (DoR) of patients.

    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.

    Measured: Baseline up to 24 months

  4. To determine the efficacy of MEN1611 in combination with eribulin defined as Progression-Free Survival (PFS).

    PFS defined as the time from the first dose of Study drugs until objective tumor progression or death, whichever occurs first.

    Measured: Baseline up to 24 months

  5. To determine the efficacy of MEN1611 in combination with eribulin defined as Overall Survival (OS).

    OS defined as the time from the first dose of Study drugs until death from any cause.

    Measured: Baseline up to 24 months

  6. To assess the safety and tolerability of MEN1611 in combination with eribulin defined as incidence and severity of adverse events.

    To evaluate the incidence of AEs of MEN1611 in combination with eribulin as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0.

    Measured: Baseline up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2023
  2. Study start24 May 2023
  3. Primary completionApr 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, single-cohort, non-comparative, open-label, phase II clinical trial.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810870
Sponsor's protocol ID
MEDOPP437
Other IDs
2022-001398-30
Acronym
SABINA
Status last verified
Sep 2025
First submitted
30 Mar 2023
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEN1611 and Eribulin in people with Breast Cancer and Advanced Breast Cancer, run by MedSIR at 13 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of MEN1611 in combination with eribulin as determined by the clinical benefit rate (CBR). (time frame: Baseline up to at least 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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