Testing Samuraciclib & Elacestrant for Advanced Breast Cancer

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    What is this study about?

    This study tests two drugs, Samuraciclib and Elacestrant, in people with a particular type of advanced breast cancer. This cancer is influenced by hormones (HR+) and does not contain a molecule known as HER2. At the beginning of the study, doctors will give a small group of patients increasing doses of these drugs to see what a safe dose is. This is the “dose escalation phase”. This safe dose will then be used in a larger group to see how well the drug combination fights cancer. During this time, you will be closely monitored for the effects of your medicines, including any side effects. Clinical trials also aim to examine how long it takes for the cancer to worsen or progress during the treatment phase, as well as to see how many people overall will benefit from the treatment.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Bordeaux , France

      Le Mans , France

      Lyon , France

      Marseille , France

      Paris , France

      Saint-Herblain , France

      A Coruu00f1a , Spain

      Barcelona , Spain

      Barcelona , Spain

      L’Hospitalet De Llobregat , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Pamplona , Spain

      Pozuelo de Alarcon , Spain

      Sevilla , Spain

      Belfast , United Kingdom

      Manchester , United Kingdom

      Nottingham , United Kingdom

      Oxford , United Kingdom

      You can join this study in:

      Study Steps

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

      In this clinical trial, patients are assigned to different cohorts, each involving specific steps and dosage regimens for the drugs samuraciclib and elacestrant. Here are the steps to be taken by patients in each cohort:

      1. Cohort 1:
        • Participants receive samuraciclib 240 mg combined with elacestrant 300 mg.
        • Treatment cycles last for 28 days each from Cycle 1 to Cycle 6.
        • For Cycles 7 to 9, treatment cycles extend to 56 days each.
        • From Cycle 10 onwards, treatment cycles may extend up to 84 days.
      2. Cohort 2:
        • Participants receive samuraciclib combined with elacestrant at the Safety Review Committee (SRC) recommended dose (anticipated to be 360mg samuraciclib, 300 mg elacestrant).
        • The duration of treatment cycles is the same as Cohort 1.
      3. Cohort 3:
        • Participants receive samuraciclib combined with elacestrant at the SRC recommended dose (anticipated to be 360mg samuraciclib, 400 mg elacestrant).
        • The duration of treatment cycles is the same as Cohort 1
      4. Cohort 4 Expansion:
        • Participants receive samuraciclib combined with elacestrant at the SRC recommended dose (anticipated to be 360mg samuraciclib, 400 mg elacestrant).
        • The duration of treatment cycles is the same as Cohort 1

      These medications are administered orally once a day.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have the following disease:

      1. Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.

      Other conditions and criteria are listed but these are not related to specific diseases. If you need additional information on other conditions or criteria, please let me know.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is the list of inclusion criteria for the study with explanations for medical terms:

      Inclusion Criteria

      1. Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer: This means that the breast cancer must be confirmed with a tissue biopsy and have receptors for estrogen (ER-positive), but not for the protein HER2 (HER2-negative). The cancer must have spread beyond the original site (locally advanced or metastatic).
      2. Documented objective disease progression while on or within 6 months after the end of the most recent therapy: The cancer must have measurably worsened during or within six months after the most recent treatment.
      3. Received prior AI in combination with a CDK4/6i as the last therapy: You must have previously been treated with an aromatase inhibitor (AI), which is a drug that lowers estrogen levels, in combination with a CDK4/6 inhibitor (CDK4/6i), which is a drug that blocks certain proteins (CDK4/6) that help cancer cells grow.
      4. Known TP53 and ESR1 mutation status: Your cancer must have been tested for mutations in the TP53 gene, which codes for a tumor suppressor protein, and the ESR1 gene, which codes for the estrogen receptor.
      5. Participants must have measurable disease or bone-only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: You need to have either a measurable size of the tumor through imaging or disease limited to bones by the standards of RECIST 1.1, which is a standardized set of criteria for assessing how well cancer responds to treatment.
      6. Pre/perimenopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to the first dose of study intervention: If you are premenopausal or perimenopausal, you should have started treatment with an LHRH agonist, which is a drug that decreases certain hormones to lower estrogen levels, at least one month before the start of the study drug.
      7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks: This is a scale that measures your ability to perform daily activities. A score of 0 means you are fully active, and a score of 1 indicates there are some symptoms, but you can still carry out light work. There should be no worsening of performance status in the last two weeks.
      8. Expected life expectancy of >12 weeks: The investigating doctor expects you to live more than 12 weeks.

      What Reasons Could Exclude Me from the Study?

      Here is the list of conditions that would exclude you from participating in the study, along with explanations of medical terms:

      Inflammatory Breast Cancer: A type of breast cancer that causes redness and swelling in the breast due to cancer cells blocking lymph vessels in the skin.

      Other Active Malignancy: Participants with any other type of cancer that is currently active or was active within the last three years. Exceptions are made for basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, if they have been adequately treated.

      Endocrine Treatment: Receipt of more than one line of hormone therapy for the treatment of locally advanced or metastatic breast cancer is not allowed.

      Inadequate Organ Function:
      – Hepatic: Poor liver function.
      – Renal: Poor kidney function.
      – Bone Marrow: Poor bone marrow function, which is responsible for producing blood cells.

      Clinically Significant Cardiovascular Disease: Any serious heart conditions that could be affected by study treatments or impact the safety of the participant.

      Central Nervous System Metastases, Carcinomatous Meningitis, or Leptomeningeal Disease: The presence of cancer cells in the brain or spinal cord, or in the membranes surrounding these areas. This includes new or previously treated metastases or inflammation of these areas due to cancer.

      Pregnant or Breastfeeding Women: If you are currently pregnant or breastfeeding, you are not eligible to participate in the study.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Samuraciclib
      – Description: Samuraciclib is administered in the form of capsules taken orally once a day.
      – Role in Study: Samuraciclib is used for treating estrogen receptor (ER)-positive and Human Epidermal Growth Factor Receptor (HER)2-negative advanced or metastatic breast cancer. Its use in the study is expected to help in understanding the safe dose when combined with elacestrant and its efficacy in participants.

      2. Elacestrant Dihydrochloride (Active substance: Elacestrant)
      – Description: Elacestrant is administered in the form of tablets taken orally once a day.
      – Role in Study: Elacestrant, also known as ORSERDU, is an investigational oral selective estrogen receptor degrader (SERD). In this study, Elacestrant is combined with Samuraciclib to determine the efficacy of this combination in treating ER-positive and HER2-negative advanced or metastatic breast cancer.

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

      The clinical trial refers to two active substances: Samuraciclib and Elacestrant. Here is a description for each:

      1. Samuraciclib: This is a CDK7 inhibitor. CDK7 plays a role in the regulation of the cell cycle, and by inhibiting CDK7, Samuraciclib potentially blocks cancer cell proliferation. The action of CDK7 inhibitors like Samuraciclib is a subject of ongoing research, with Samuraciclib being evaluated for its safety and effectiveness in clinical settings, specifically for hormone receptor-positive and human epidermal growth factor receptor 2-negative breast cancer.

      2. Elacestrant: It is a novel, orally bioavailable selective estrogen receptor degrader (SERD). Elacestrant binds to estrogen receptors and promotes their destruction, thus inhibiting the impact of estrogen on breast cancer cells. This type of therapy is generally used to treat estrogen receptor-positive breast cancer, which relies on estrogen to grow and spread.

      Both substances are subject to ongoing studies to establish their efficacy and safety profiles in treating breast cancers, particularly in conditions where the cancer has progressed despite other forms of hormone therapy .


      Study ID

      CT-EU-00038637

      Recruitment status

      Recruting new patients

      Start of the trial

      9 months ago

      Study phase

      Phase
      I

      Diseases