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Study on Ribociclib and Drug Combination for Patients with Advanced HER2-Negative, Hormone Receptor Positive Breast Cancer

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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 and resistance of the medication Ribociclib in patients with advanced breast cancer. Specifically, it targets those with a subtype known as HER2-negative, hormone receptor positive (HER2neg/HR+) breast cancer. The study aims to understand how well Ribociclib works when used in combination with other treatments, such as anastrozole, exemestane, fulvestrant, and letrozole, which are all medications used to treat breast cancer. These medications are taken orally, except for fulvestrant, which is given as an injection.

The purpose of the study is to estimate the survival rates of patients, focusing on how long they live without the cancer getting worse and their overall survival at 12 months. Participants will receive treatment for up to 48 months, during which they will take Ribociclib and one of the other medications mentioned. Some participants may receive a placebo instead of one of the medications to help compare the effects. The study will monitor the participants' health and any side effects they experience during this period.

Throughout the study, participants will have regular check-ups and tests to track their progress and the effectiveness of the treatment. The study will also assess the quality of life of the participants using a questionnaire called FACT-G/FACT-B, which is designed to measure health-related quality of life in cancer patients. The ultimate goal is to gather comprehensive data on how Ribociclib and the other medications work together in treating advanced breast cancer, providing valuable insights for future treatments.

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

    Initial visit and consent

    Upon joining the study, you will have an initial visit where you will be asked to provide written informed consent. This means you agree to participate in the trial after understanding all the procedures and potential risks involved.

    During this visit, your eligibility for the trial will be confirmed. This includes confirming that you have advanced HER2-negative, hormone receptor-positive breast cancer and meet other specific health criteria.

  2. Step 2

    Treatment plan discussion

    A detailed discussion about your treatment plan will take place. You will be informed about the medications you will be taking, which include ribociclib and one of the following endocrine therapies: anastrozole, exemestane, fulvestrant, or letrozole.

    The method of taking these medications will be explained. Ribociclib, anastrozole, exemestane, and letrozole are taken orally, while fulvestrant is administered through an intramuscular injection.

  3. Step 3

    Medication administration

    You will begin taking the medications as prescribed. The dosage and frequency will be determined by your healthcare provider based on your specific condition and needs.

    The duration of the medication administration will be explained, and you will be required to follow the schedule strictly to ensure the effectiveness of the treatment.

  4. Step 4

    Regular follow-up visits

    You will have regular follow-up visits to monitor your health and the effectiveness of the treatment. These visits will include physical examinations, laboratory tests, and discussions about any side effects you may experience.

    Your healthcare provider will assess your progression-free survival and overall survival at specific intervals, such as at 12 months.

  5. Step 5

    End of trial procedures

    At the end of the trial, you will undergo final assessments to evaluate the overall impact of the treatment on your health.

    You will be informed about the results of the trial and any further steps or treatments that may be recommended based on your condition.

Who can join the trial?

11 criteria

  • The patient must have advanced **HER2-negative**, **hormone receptor positive** breast cancer. This means the cancer does not have a protein called HER2 and has receptors for hormones like estrogen or progesterone.
  • The patient should be eligible for treatment with **ribociclib** combined with hormone therapy for advanced or first-time metastatic breast cancer. Previous use of similar drugs in early treatment is allowed.
  • The patient must be willing and able to attend scheduled visits, follow treatment plans, and undergo necessary tests and procedures.
  • The patient must provide written consent to participate in the trial.
  • The patient must be a female aged 18 years or older.
  • The breast cancer must be locally advanced or metastatic, meaning it cannot be cured with surgery or radiation.
  • The patient must have **HER2-negative** breast cancer confirmed by specific lab tests.
  • The cancer must be confirmed as **ER positive** and/or **PgR positive** through a biopsy, which is a sample of tissue taken for testing.
  • The patient must have a **QTcF interval** of less than 450 ms. This is a measure of heart rhythm checked by an ECG test.
  • The patient must have organs functioning well enough to receive treatment with ribociclib, as determined by lab tests.
  • Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the trial and for 21 days after the last treatment dose.

Who cannot join the trial?

4 criteria

  • Patients who do not have advanced **HER2-negative, hormone receptor positive (HER2neg/HR+) breast cancer**.
  • Patients who are not in the **first line therapeutic setting**. This means patients who have already received treatment for their breast cancer.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are considered part of a **vulnerable population**. This typically includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Ribociclib is a medication used in this clinical trial to treat advanced breast cancer. It works by blocking certain proteins in cancer cells that are responsible for their growth and division. By inhibiting these proteins, Ribociclib can help slow down or stop the progression of cancer, potentially improving survival rates for patients. This trial aims to understand how effective Ribociclib is over time and why some patients may develop resistance to it.

What is already known about the treatment

Ribociclib – Ribociclib is administered orally in the form of tablets. It is currently used in medicine to treat patients with advanced HER2-negative, hormone receptor-positive breast cancer, particularly in the first line of therapy. The medication works by inhibiting certain proteins in cancer cells, which are responsible for cell division and growth, thereby slowing down the progression of the disease. Ribociclib belongs to a class of drugs known as CDK4/6 inhibitors, which are designed to target specific molecules involved in the cell cycle of cancer cells.

Investigated diseases

Advanced HER2-negative, hormone receptor-positive breast cancer – This type of breast cancer is characterized by the absence of the human epidermal growth factor receptor 2 (HER2) and the presence of hormone receptors, such as estrogen or progesterone receptors. It typically progresses by relying on hormones to grow and spread. As the disease advances, it may spread beyond the breast to other parts of the body, such as bones, liver, or lungs. The progression can lead to symptoms like lumps in the breast, changes in breast shape, or pain in affected areas. Over time, the cancer may become resistant to hormone therapies, leading to further progression. The disease's behavior can vary significantly among individuals, affecting the rate and pattern of progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500764-35-00Protocol codeIFG-01-2022Estimated enrolment2 000 patientsSponsorInstitut fuer Frauengesundheit GmbH

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