Evaluation of the effect of ixabepilone in advanced breast cancer

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    What is this study about?

    A clinical study is evaluating the effects of a drug named ixabepilone on advanced breast cancer after other common treatments haven’t worked. The study involves 60 people receiving the drug through an infusion every three weeks. Researchers will look at how well the cancer responds to the treatment, including how long participants live without their cancer getting worse and the overall survival rate. The study is for adults with certain types of advanced breast cancer and will not include healthy volunteers.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Antwerp , Belgium

      Aalst , Belgium

      Brussels , Belgium

      Liege , Belgium

      Tampere , Finland

      Berlin , Germany

      Modena , Italy

      Rotterdam , Netherlands

      Biala Podlaska , Poland

      Gdau0144sk , Poland

      Lublin , Poland

      Poznau0144 , Poland

      Gillingham , United Kingdom

      Glasgow , United Kingdom

      Taunton , United Kingdom

      Swansea , United Kingdom

      Edinburgh , United Kingdom

      Leeds , United Kingdom

      You can join this study in:

      Belgium: Aalst, Antwerp, Brussels, Liège.

      Germany: Berlin.

      Poland: Biała Podlaska, Lublin.

      United Kingdom: Edinburgh, Gillingham, Glasgow, Leeds, Swansea, Taunton.

      Italy: Modena.

      Netherlands: Rotterdam.

      Finland: Tampere.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial are as follows:

      1. Patient screening with the Ixabepilone DRP (Drug Response Prediction).
      2. If the tumor tissue has a DRP score of >67% (in Belgium >33%), the patient can be included in the clinical study.
      3. Ixabepilone is administered at a dose of 40 mg/m2 as a 3-hour intravenous infusion on Day 1 in a 3-week cycle.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a histologically or cytologically confirmed carcinoma of the breast. Specifically, the study includes patients with either:

      1. HR-positive, HER2-negative tumors
      2. Triple-negative tumors (that do not express estrogen receptors, progesterone receptors, or HER2)

      These are considered eligible diseases if they are locally recurrent or metastatic.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is a list of the inclusion criteria for the study, with explanations of medical terms where applicable:

      1. Signed informed consent form – You need to have had the study explained to you and must have signed a form agreeing to participate.
      2. Age 18 years or older – You need to be an adult to participate.
      3. Diagnosed breast cancer – Your breast cancer must be confirmed through histology (the study of the microscopic structure of tissues) or cytology (the study of individual cells).
      4. Hormone Receptor (HR)-positive or Triple-negative tumors – HR-positive tumors have receptors that hormones like estrogen or progesterone can attach to and influence cancer growth. HER-negative means the cancer does not have an excess of the HER2 protein on its surface. Triple-negative tumors lack receptors for estrogen, progesterone, and excess HER2 protein.
      5. Prior therapies should include a taxane and an anthracycline – Your previous cancer treatments should have included these two types of chemotherapy unless anthracyclines were not appropriate for your treatment.
      6. Limited number of prior chemotherapies – You should not have had more than three chemotherapies for metastatic breast cancer, but there is no limit on endocrine (hormonal) therapy lines you might have had.
      7. Measurable disease – There must be at least one tumor that can be accurately measured using imaging techniques.
      8. Performance status – Your general well-being must be good enough, with an Eastern Cooperative Oncology Group (ECOG) score of ≤1, meaning you are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work. The ECOG scale is used to assess how a patient’s disease is progressing, how the disease affects the daily living abilities of the patient, and helps to determine the appropriate treatment and prognosis.
      9. Ixabepilone DRP score – You require a DRP (Drug Response Predictor) score of >33% or >67% for Germany to predict your potential response to the drug Ixabepilone.
      10. Adequate laboratory values – Your blood and organ function tests need to meet certain thresholds to indicate your body can handle the treatment. For example, your ANC (Absolute Neutrophil Count) must be at a level that indicates an acceptable number of white blood cells to fight infection (≥ 1.5 x 10⁹/L), Hemoglobin (a measure of your blood’s oxygen-carrying capacity) must be > 6.2 mmol/L, etc.
      11. Effective contraception use if of childbearing potential – You must agree to use reliable methods of birth control to prevent pregnancy during the study and for a set period after the last dose of the study drug. Such methods have a low rate of failure (less than 1% per year) when used consistently and correctly.

      Note: The DRP score mentioned is specific to how the patient’s tumors might respond to the trial medication, Ixabepilone. It is a percentage score derived from genomic testing.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would make you ineligible to participate in the study, along with explanations of some medical terms:

      1. HER2 positive tumor: A tumor that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which can promote the growth of cancer cells.
      2. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug: If you are currently receiving these treatments for other conditions, you are excluded, except in cases where the therapy is unrelated to the disease being studied (e.g. using insulin for diabetes).
      3. Patients with intracranial disease: If you have any disease involving the brain or other parts of the head.
      4. Other malignancy: If you have had another type of cancer, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, that was curatively treated within the last 5 years.
      5. Any active infection requiring antibiotics: If you have an ongoing infection that needs treatment with antibiotics, whether taken orally or through injections (parenteral).
      6. Neuropathy: A condition affecting the nerves, causing weakness, numbness, or pain, especially in the hands and feet. You are excluded if you have grade 2 neuropathy, or grade 1 neuropathy if you have diabetes.
      7. Clinically significant cardiovascular disease: Includes conditions like recent strokes, transient ischemic attacks, heart attacks, unstable angina, congestive heart failure of NYHA Class II or higher, or serious heart rhythm problems needing medication.
      8. Other conditions that may interfere with safe participation or data integrity: This could include medications, other diseases, or surgical procedures that the study investigator thinks might pose a safety risk or affect study results.
      9. Immediate palliative treatment requirement: If you need urgent treatment to alleviate symptoms or pain, such as surgery or radiotherapy.
      10. Pregnancy or breast-feeding: Female patients who are pregnant, confirmed by a positive pregnancy test before study entry, or are currently breast-feeding are excluded.
      11. Severe hypersensitivity reactions: If you have known severe allergic reactions to agents containing polyoxyethylated castor oil (Cremophor EL), or known hypersensitivity to fluoropyrimidines.
      12. Dihydropyrimidine dehydrogenase (DPD) deficiency: A known or suspected genetic condition that affects the metabolism of certain chemotherapy drugs.
      13. Use of certain strong inhibitors of CYP3A4: Treatment with specific medications that strongly inhibit a liver enzyme called CYP3A4 must be discontinued before the start of the study.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drug involved in the study is Ixabepilone. Here is a brief description of the active substance:

      1. Ixabepilone: It is a semi-synthetic analog of epothilone B, which is a natural product isolated from the myxobacterium Sorangium cellulosum. Ixabepilone works as a microtubule inhibitor, stabilizing the microtubules and preventing cell division which results in apoptosis, or programmed cell death, of cancer cells. It is used for the treatment of metastatic or locally advanced breast cancer, usually after the failure of other chemotherapy drugs including anthracyclines and taxanes. In the clinical trial, ixabepilone is administered as a 3-hour intravenous infusion on the first day of a 3-week cycle at a dose of 40 mg/m2.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance that is being used in the clinical trial is Ixabepilone. Ixabepilone is well-known in the field of medicine and has been mentioned in medical literature primarily for its use in cancer treatment, particularly breast cancer. Ixabepilone is a microtubule inhibitor, meaning it works by inhibiting cell division, which is a significant function for cancer treatment as it prevents cancer cells from multiplying.

      Here is a brief description of ixabepilone:

      1. Ixabepilone: This drug is administered as a 40 mg/m2 dose via a 3-hour intravenous infusion on the first day of a 3-week cycle in the clinical study. Ixabepilone is a type of chemotherapeutic agent known as an epothilone B analog. It has been approved by regulatory agencies like the FDA for use in the treatment of aggressive or metastatic breast cancer, especially in cases where tumors are resistant to anthracyclines and taxanes, or when further anthracycline therapy is not indicated.

      Ixabepilone’s efficacy and safety profile have been established through previous clinical trials and its use in medical practice.


      Study ID

      CT-EU-00026378

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      II

      Medicinal Product

      Diseases