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Study of MEN1611 and Eribulin for Advanced Metaplastic Breast Cancer in Patients with PIK3CA/PTEN Alterations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as metaplastic breast cancer, which is advanced and cannot be surgically removed. The study is specifically looking at cases where there are changes in certain genes, called PIK3CA and PTEN. These changes can affect how the cancer grows. The trial is testing a treatment using a medication called MEN1611, which is taken as a capsule, either by itself or in combination with another medication called eribulin, which is given as an injection.

The purpose of the study is to see how effective these treatments are for patients with this specific type of breast cancer. The study is divided into two groups. In one group, patients will receive MEN1611 alone, and in the other group, patients will receive MEN1611 together with eribulin. The study will monitor how the cancer responds to these treatments over a period of time.

Participants in the study will receive the treatment and be regularly monitored by healthcare professionals. The study will track the progress of the cancer and any changes in the patient's condition. The goal is to determine if these treatments can help control the cancer and improve the patient's quality of life. The study will also look at any side effects that may occur during the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation begins with the administration of the first dose of the study medications.

    The study involves two groups: one receiving a combination of medications and the other receiving a single medication.

  2. Step 2

    Medication administration

    For those in the combination group, the treatment includes eribulin and MEN1611. Eribulin is given as an intravenous injection, while MEN1611 is taken orally in capsule form.

    The dosage for eribulin is 0.44 mg/ml, and for MEN1611, it is 16 mg per capsule.

  3. Step 3

    Treatment cycles

    The treatment is administered in cycles. Each cycle lasts for a specified period, after which the patient's response to the treatment is evaluated.

    The primary goal for the combination group is to assess the clinical benefit rate, which includes complete response, partial response, or stable disease for at least 12 weeks.

  4. Step 4

    Evaluation of response

    For the group receiving MEN1611 alone, the objective response rate is evaluated at 6 weeks to determine the effectiveness of the treatment.

    The evaluation includes measuring tumor response and monitoring any changes in the condition.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the patient's health and any side effects from the medications.

    The study aims to evaluate the incidence of adverse events and their severity.

  6. Step 6

    Completion of study

    The study is estimated to conclude by December 30, 2026.

    Upon completion, the overall outcomes and effectiveness of the treatments will be analyzed.

Who can join the trial?

20 criteria

  • The patient must be able to sign a written form before any testing during the pre-screening phase.
  • The patient must have a confirmed PIK3CA mutation or PTEN loss by a certified laboratory.
  • Patients with stable brain tumors who are not on steroid or seizure medication can participate if they had certain treatments like radiotherapy or surgery within specific time frames before starting the study treatment.
  • The patient must have a confirmed diagnosis of metaplastic breast carcinoma (MpBC).
  • Any side effects from previous cancer treatments must be resolved to a mild level, except for hair loss or other non-risky side effects.
  • The patient must provide a recent tumor sample from a biopsy or surgery.
  • The patient must be 18 years or older.
  • The patient must have a known hormone receptor (HR) status and HER2-negative breast cancer.
  • The patient must have had at least one but no more than four previous treatments for advanced disease.
  • The patient must not have had previous treatment with certain inhibitors or the drug eribulin (for specific groups).
  • The patient must agree to provide a tumor or blood sample for testing.
  • Women who can have children must agree to use effective birth control methods during the study and for a period after the study ends. They must also have a negative pregnancy test before starting the study.
  • The patient must be able to sign a written consent form before participating in any study activities.
  • The patient must have adequate blood and organ function as determined by specific medical tests.
  • Men must be surgically sterile or agree to use birth control methods during the study and for a period after the study ends.
  • The patient must have a performance status of 0 or 1, meaning they are fully active or have some restrictions but can still perform light work.
  • The patient must be available for treatment and follow-up visits.
  • For specific groups, the patient must have measurable or evaluable disease as defined by certain criteria.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have advanced or metastatic MpBC that cannot be surgically removed with the intent to cure.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have had a different cancer treatment recently that might interfere with the study.
  • Patients with serious health problems that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study might affect the baby.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have allergies to the study medications or similar drugs.
  • Patients who are participating in another clinical trial at the same time.
  • Patients with certain infections that could be worsened by the study treatment.
  • Patients with a history of drug or alcohol abuse that might affect their ability to participate.
  • Patients who have had a recent surgery that could interfere with the study.
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Investigated drugs

  • MEN1611

    is an investigational medication being studied for its potential to treat advanced metaplastic breast cancer that has specific genetic alterations. In this trial, MEN1611 is being tested both as a standalone treatment and in combination with another medication. The goal is to see how effective it is in slowing down or stopping the growth of cancer in patients with these specific genetic changes.

  • Eribulin

    is a chemotherapy drug that is already used to treat certain types of breast cancer. In this study, it is being combined with MEN1611 to see if the combination is more effective than MEN1611 alone. Eribulin works by interfering with the growth of cancer cells, which may help to control the disease.

What is already known about the treatment

MEN1611 – MEN1611 is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced metaplastic breast cancer that is hormone receptor-known, HER2-negative, and has specific genetic alterations. It is being evaluated both as a monotherapy and in combination with another drug, eribulin. The main therapeutic indication is for patients with unresectable locally advanced or metastatic breast cancer with PIK3CA or PTEN alterations. MEN1611 works by inhibiting the PI3K pathway, which is involved in cell growth and survival, thereby potentially slowing down or stopping the growth of cancer cells. It is classified as a PI3K inhibitor in pharmacology.

Investigated diseases

Metaplastic Breast Carcinoma – Metaplastic breast carcinoma is a rare and aggressive form of breast cancer characterized by the presence of different types of cells within the tumor. It often presents as a large, palpable mass in the breast and can be difficult to diagnose due to its varied cellular composition. This type of cancer is known for its rapid growth and potential to spread to other parts of the body. It is typically hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)-negative, which means it does not respond to hormonal therapies or HER2-targeted treatments. The disease may also involve genetic alterations such as PIK3CA and PTEN mutations, which can influence its behavior and progression. Due to its unique characteristics, metaplastic breast carcinoma often requires specialized treatment approaches.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512963-30-00Protocol codeMEDOPP437Estimated enrolment14 patientsSponsorMedica Scientia Innovation Research S.L.

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