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Study of Fulvestrant and Samuraciclib for Patients with Advanced HR Positive, HER2-Negative Breast Cancer

Verified siteRegistered 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 a type of breast cancer known as metastatic or locally advanced hormone receptor-positive and HER2-negative breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2, which can influence cancer growth. The study involves two treatments: Fulvestrant, a medication given as an injection, and Samuraciclib, also known by its code name CT7001, which is taken as a tablet. The purpose of the study is to evaluate how effective these treatments are when used together.

Participants in the study will receive either Fulvestrant alone or in combination with Samuraciclib. Fulvestrant is administered through an injection into the muscle, while Samuraciclib is taken orally as a tablet. The study will last for a period of up to 24 months, during which the effects of the treatments will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the results with those receiving the actual treatment.

The study aims to observe the clinical benefits, such as complete or partial response to the treatment or stable disease, and to monitor any side effects or adverse events. The trial will also measure how long participants live without the cancer getting worse, known as progression-free survival, and the overall response rate to the treatment. This research is important for understanding how these medications can help manage this specific type of breast cancer and improve treatment options for patients in the future.

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 participant will be informed about the trial's purpose, which is to evaluate the effectiveness of two doses of samuraciclib in combination with fulvestrant.

    The participant will be required to have a confirmed diagnosis of breast cancer that is either metastatic or locally advanced, and hormone receptor positive and HER2-negative.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility, including a review of medical history and current health status.

    The participant must have measurable disease or bone-only disease as defined by specific criteria.

  3. Step 3

    Treatment phase

    The treatment involves receiving fulvestrant through intramuscular injection and CT7001 (samuraciclib) in tablet form taken orally.

    The specific dosage and frequency of administration will be determined by the study protocol and communicated to the participant.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the participant's response to the treatment, including clinical benefit response, which may include complete response, partial response, or stable disease.

    The participant will be monitored for any adverse events or laboratory abnormalities.

  5. Step 5

    Completion of the study

    The study is estimated to end by July 31, 2025, at which point the participant's overall response and progression-free survival will be evaluated.

    The duration of response and other secondary outcomes will also be assessed.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of breast cancer that is either **metastatic** (spread to other parts of the body) or **locally advanced** (grown into nearby areas) and cannot be treated with surgery or radiation to cure it. The cancer must be **estrogen receptor positive** (cancer grows in response to estrogen) and **HER2-negative** (does not have high levels of a protein called HER2).
  • The patient must have shown disease progression, meaning the cancer has gotten worse, while on or within 6 months after the last treatment.
  • The patient must have previously received a type of treatment called **AI** (aromatase inhibitor) along with **CDK4/6i** (a type of drug that blocks certain proteins involved in cancer cell growth) for advanced or metastatic cancer, or as an additional treatment after surgery.
  • The patient must know their **TP53 mutation status**, which refers to a specific change in a gene that can affect cancer growth.
  • The patient must have cancer that can be measured or is only in the bones, as defined by specific criteria used to assess tumors.
  • If the patient is premenopausal or perimenopausal (before or around menopause), they must have started treatment with a **luteinizing hormone-releasing hormone (LHRH) agonist** (a drug that affects hormone levels) at least 4 weeks before the first dose of the study treatment.
  • The patient must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work. There should be no worsening of their condition in the last 2 weeks.
  • The patient must have a life expectancy of more than 12 weeks, as judged by the doctor treating them.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not **breast cancer**.
  • Patients who have **breast cancer** that is not **Hormone Receptor positive** or **Human Epidermal Growth Factor Receptor 2 negative**.
  • Patients who are not in the age range specified for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
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Investigated drugs

  • Fulvestrant

    is a medication used in the treatment of certain types of breast cancer. It works by blocking the effects of estrogen in the body, which can help slow down or stop the growth of cancer cells that need estrogen to grow.

  • Samuraciclib

    is an investigational drug being studied for its potential to treat breast cancer. It is being tested in combination with fulvestrant to see if it can enhance the effectiveness of the treatment in patients with hormone receptor-positive and HER2-negative breast cancer.

What is already known about the treatment

  • Fulvestrant

    Fulvestrant is administered as an injection into the muscle, typically in the buttocks. It is currently approved and widely used in the treatment of certain types of breast cancer, specifically hormone receptor-positive and HER2-negative breast cancer. The medication works by binding to estrogen receptors and degrading them, which helps to slow the growth of cancer cells that rely on estrogen. Fulvestrant is classified as an estrogen receptor antagonist.

  • Samuraciclib

    Samuraciclib is an investigational drug administered orally in pill form. It is currently being studied in clinical trials for its potential use in treating hormone receptor-positive and HER2-negative breast cancer. The drug works by inhibiting cyclin-dependent kinases, which are enzymes that play a role in cell division, thereby potentially slowing the growth of cancer cells. Samuraciclib is classified as a CDK inhibitor.

Investigated diseases

Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is also negative for the Human Epidermal Growth Factor Receptor 2 (HER2), which means it does not overexpress the HER2 protein. This cancer can be either metastatic, meaning it has spread to other parts of the body, or locally advanced, indicating it has grown significantly in the breast or nearby areas but not spread to distant organs. The progression of this disease can vary, with some cases remaining stable for extended periods, while others may grow or spread more rapidly. The growth and spread of the cancer are influenced by the presence of hormone receptors, which can drive the proliferation of cancer cells. Understanding the hormone receptor status is crucial in determining the course of the disease and potential treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503903-27-00Estimated enrolment60 patientsSponsorCarrick Therapeutics Limited

sourced from the EU Clinical Trials Register and site verification

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