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Study on the Effects of Selumetinib, Bicalutamide, and Olaparib in Patients with Metastatic Breast Cancer

Fast replyRegistered drugNo placebo
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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 the effectiveness of treatments for metastatic breast cancer, which is a type of breast cancer that has spread to other parts of the body. The study will use a combination of medications, including Selumetinib, Casodex (which contains the active substance Bicalutamide), and Olaparib. These medications are taken orally and are designed to target specific pathways in cancer cells to stop their growth. Selumetinib is a type of medication known as a kinase inhibitor, Casodex is an antiandrogen, and Olaparib is a PARP inhibitor.

The purpose of the study is to compare how long patients can live without their cancer getting worse when treated with these medications compared to standard chemotherapy. Participants will be randomly assigned to receive either the experimental treatment or a standard chemotherapy regimen. Some participants may receive a placebo. The study will last for up to 12 months, during which time participants will take the study medications and attend regular check-ups to monitor their health and the progression of their cancer.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI to evaluate the size and spread of their cancer. The study aims to provide valuable information on whether these new treatment combinations can improve outcomes for patients with metastatic breast cancer. The ultimate goal is to find more effective treatment options that can help patients live longer and with a better quality of life.

The research process

The trial runs in 5 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, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the trial.

    A negative pregnancy test is required for women with childbearing potential within 14 days before starting the study medication.

    The patient must be able to swallow oral capsules and have a normal heart function as shown by an echocardiogram.

  2. Step 2

    Initial assessment

    The patient must have a confirmed diagnosis of breast adenocarcinoma with specific molecular changes.

    There should be evidence of inoperable locally advanced or metastatic breast cancer.

    Measurable lesions must be present according to specific criteria, and a biopsy or a recent tumor sample is required.

  3. Step 3

    Medication administration

    The patient will receive medications orally. The medications include selumetinib, bicalutamide (known as Casodex 50 mg film-coated tablets), and olaparib.

    The specific dosage and frequency of these medications will be determined by the study protocol and communicated to the patient by the healthcare provider.

  4. Step 4

    Monitoring and follow-up

    The patient's progression-free survival will be monitored and compared to standard chemotherapy outcomes.

    Overall survival will also be assessed as a secondary measure.

    Regular follow-up appointments will be scheduled to monitor the patient's response to the treatment and any side effects.

  5. Step 5

    Completion of the study

    The estimated end date for the study is December 1, 2025.

    Upon completion, the patient's overall health and treatment outcomes will be evaluated.

Who can join the trial?

13 criteria

  • Must sign an informed consent form, which means agreeing to participate after understanding the study details.
  • Expected to live for at least 3 more months.
  • If a woman can have children, she must have a negative pregnancy test within 14 days before starting the study medication.
  • Must be able to swallow pills.
  • Must have a normal heart function test, with specific measurements: **LVEF** (Left Ventricular Ejection Fraction) greater than 50% and **SF** (Shortening Fraction) greater than 15%.
  • Must have breast cancer confirmed by a tissue examination.
  • Must have specific changes in the cancer cells, as shown by tests.
  • Must have breast cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Must have tumors that can be measured using specific guidelines called **RECIST criteria v1.1**. Certain bone lesions that can be seen on an **MRI** (Magnetic Resonance Imaging) can also be measured.
  • Must have a tumor that can be biopsied, or have a sample of the tumor taken within the last 6 months. If only bone lesions are present, a biopsy is not required, but a tumor sample is needed.
  • Must be older than 18 years.
  • Must have a **PS** (Performance Status) of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
  • Must show that the disease is getting worse. There is no limit to the number of previous cancer treatments received for the disease. If the cancer is **HER2+** (a type of breast cancer), must have had two or more treatments targeting HER2, including specific drugs like pertuzumab/trastuzumab and T-DM1.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic breast cancer cannot participate. This means the cancer has spread to other parts of the body.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are considered part of a vulnerable population are excluded. This refers to groups who may have additional risks or need special protection in research.
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Investigated drugs

SHARP is a new experimental therapy being tested for its effectiveness in treating metastatic breast cancer. It uses advanced sequencing technology to help doctors make better treatment decisions based on the genetic makeup of the cancer. This approach aims to improve the time patients live without their cancer getting worse compared to traditional chemotherapy treatments.

What is already known about the treatment

SHARP Oncochip – This medication is administered through a next-generation sequencing-based method, specifically designed for therapeutic decision-making in metastatic breast cancer. Currently, it is under clinical investigation to assess its effectiveness compared to standard chemotherapy. The main therapeutic indication is for patients with metastatic breast cancer, aiming to improve progression-free survival. The mechanism of action involves analyzing genetic information to tailor personalized treatment strategies, potentially enhancing the effectiveness of cancer therapy. It falls under the pharmacological classification of precision medicine tools, focusing on individualized treatment approaches.

Investigated diseases

Metastatic Breast Cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is considered an advanced stage of breast cancer and can develop years after the initial diagnosis and treatment of breast cancer. The cancer cells in metastatic breast cancer are the same as those in the original breast cancer. As the disease progresses, it can cause symptoms related to the areas where the cancer has spread, such as bone pain or difficulty breathing. The progression of the disease can vary greatly among individuals, with some experiencing rapid changes and others having a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513934-40-00Estimated enrolment400 patientsSponsorIstituto Europeo Di Oncologia S.r.l.

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