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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Marienhospital Bottrop gGmbH Bottrop Germany
Evangelisches Krankenhaus Bergisch Gladbach gGmbH Bergisch Gladbach Germany
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR Freiburg Im Breisgau Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Saarland University Hospital Homburg Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Romed Klinikum Rosenheim Rosenheim Germany
Klinikum Kulmbach Kulmbach Germany
Unjmoinerc Mllacct Cqfqnp Hbbaujurzufymjsar Hamburg Germany
Ugmyxkqzarbtndiwugasy Atttjuyn Augsburg Germany
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
30.06.2025

Trial locations

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.

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 ID:
2024-520290-12-00
Protocol code:
IFG-01-2024
Trial Phase:
Therapeutic confirmatory (Phase III)

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