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Study of typology-based coaching and education to help patients with early hormone-positive HER2-negative breast cancer manage their treatment with ribociclib

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 study focuses on patients with hormone receptor-positive/HER2-negative early breast cancer, which is a type of breast cancer that tests positive for hormone receptors but negative for a protein called HER2. The treatment being studied is ribociclib (also known as Kisqali), which is taken as film-coated tablets by mouth. Ribociclib belongs to a group of medications called CDK4/6 inhibitors that help control cancer cell growth.

The purpose of this research is to evaluate how patient education and personalized coaching affect how long patients continue their treatment with ribociclib. The study will examine different approaches to supporting patients through their treatment journey and measure how these approaches impact treatment continuation.

During the study, participants will take ribociclib tablets daily and receive specialized coaching support. Throughout the treatment period, which lasts up to 36 months, patients will complete questionnaires about their quality of life and overall well-being. They will also keep a diary to track any breaks in their treatment. The study will monitor how patients manage their treatment and any side effects that may occur.

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 treatment phase

    You will receive ribociclib (Kisqali) in the form of film-coated tablets that you take by mouth

    The treatment will be combined with an aromatase inhibitor (a hormone therapy medication)

    Your doctor will confirm that your breast cancer is hormone receptor-positive and HER2-negative before starting treatment

  2. Step 2

    Regular health assessments

    Your organ function will be checked regularly through laboratory tests

    You will need to maintain a patient diary to record any breaks in treatment

    Health evaluations will occur after 3, 6, 9, 12, 24, and 36 months of treatment

  3. Step 3

    Quality of life monitoring

    You will complete questionnaires about your well-being and quality of life

    The questionnaires include the FACT-B (which measures how breast cancer affects your daily life)

    You will also complete the EQ-5D questionnaire and rate your distress levels

  4. Step 4

    Safety monitoring

    Any side effects will be recorded and rated according to standard criteria

    Your doctor will monitor your health throughout the 36-month treatment period

    Female participants who can become pregnant must use effective birth control methods and have pregnancy tests

  5. Step 5

    Long-term follow-up

    The treatment and monitoring will continue for up to 36 months

    Your overall health status will be evaluated at 6, 12, and 36 months

    The study will track how long you stay on the treatment and any reasons for stopping

Who can join the trial?

11 criteria

  • Must sign a written consent form before starting any study procedures
  • Must be 18 years or older when signing the consent form
  • Must have confirmed breast cancer (specifically invasive adenocarcinoma, which is a type of breast cancer that starts in the glands)
  • Must have breast cancer that is hormone receptor-positive (meaning the cancer cells grow in response to hormones)
  • Must have HER2-negative breast cancer (meaning the cancer cells don't have high levels of a protein called HER2)
  • Must be suitable for treatment with ribociclib (a cancer medication) combined with an aromatase inhibitor (a hormone therapy medication)
  • Must have adequate organ function to receive ribociclib treatment, as determined by laboratory tests
  • For women who can become pregnant:
    • Must have had a hysterectomy (surgical removal of the uterus), or
    • Must use reliable birth control methods
    • Must have a negative pregnancy test
    • Must be willing and able to attend all scheduled appointments and follow the treatment plan

Who cannot join the trial?

12 criteria

  • Previous severe allergic reactions to ribociclib or similar medications
  • Currently participating in other clinical trials
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Severe heart conditions or uncontrolled cardiovascular disease (heart and blood vessel problems)
  • Severe liver problems or abnormal liver function tests
  • Untreated or uncontrolled brain metastases (cancer spread to the brain)
  • Currently taking medications that can interact with ribociclib
  • Unable to swallow oral medications
  • Pregnant or breastfeeding women
  • History of other cancers within the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Mental conditions that could interfere with following study procedures
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

Ribociclib is a targeted therapy medication used in the treatment of hormone receptor-positive (HR+), HER2-negative breast cancer. It belongs to a class of drugs called CDK4/6 inhibitors, which work by blocking specific proteins that help cancer cells grow and divide. This medication is taken orally and is used as part of adjuvant treatment, which means it's given after primary treatment (such as surgery) to help prevent cancer recurrence. The study also includes a coaching intervention, which is not a medication but rather an educational and support program designed to help patients better manage their treatment. This typology-based coaching approach is personalized according to individual patient characteristics to improve how patients handle their medication routine.

What is already known about the treatment

Ribociclib - A targeted oral medication used in breast cancer treatment, specifically for hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This drug belongs to the class of CDK4/6 inhibitors and works by blocking specific proteins that promote cancer cell growth and division. Ribociclib is administered as tablets taken daily according to a prescribed schedule, typically in combination with hormone therapy as part of an adjuvant treatment plan. The medication has shown significant effectiveness in early-stage breast cancer patients who are at risk of recurrence, helping to prevent cancer cells from multiplying.

Investigated diseases

Hormone receptor-positive/HER2-negative breast cancer - A type of breast cancer where cancer cells have receptors for estrogen and/or progesterone hormones (hormone receptor-positive) but lack excess HER2 protein (HER2-negative). This is the most common form of breast cancer. The cancer cells in this type depend on hormones to grow and multiply. In early-stage cases, the cancer is confined to the breast or nearby lymph nodes. The cancer cells maintain normal levels of HER2 protein on their surface, which influences how the disease develops and responds to the body's signals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520290-12-00Protocol codeIFG-01-2024Estimated enrolment548 patientsSponsorInstitut fuer Frauengesundheit GmbH

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