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RecruitingPHASE4INTERVENTIONAL

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

This study is for women with a type of advanced breast cancer called HR+/HER2- breast cancer who are starting their first treatment with ribociclib and other standard hormone therapy. Researchers want to understand how ribociclib works over time, why it’s effective for some, and why it might stop working for others. They will collect samples from patients to look at tiny biological markers (like DNA and RNA) which might help predict how well the treatment will work. The study will also track how long patients live without their cancer getting worse, their overall survival, their quality of life, and any side effects from the treatment.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Institut fuer Frauengesundheit
Enrolment target
1,000
Start
12 Oct 2022
Estimated completion
01 Oct 2026

What is this study about?

This study is called a 'Phase 4' study, which means the drug ribociclib is already approved, and researchers are now gathering more information about its real-world use. They're focusing on women who have advanced breast cancer that is positive for hormone receptors (HR+) and negative for HER2 (HER2-). This is a common type of breast cancer. The women in the study will be starting ribociclib for the first time, along with other usual hormone treatments, just as their doctor would normally prescribe it.

The main goals are to see how long patients live without their cancer getting worse (this is called 'progression-free survival') and how long they live overall when treated with ribociclib. The researchers also want to understand if certain tiny biological clues, or 'biomarkers,' found in blood or tissue samples can help predict who will respond best to the treatment or why the treatment might stop working for some patients. This could help doctors in the future make more personalised treatment choices.

They will also be looking at important things like how the treatment affects a patient's quality of life and what side effects they might experience. By gathering all this information, scientists hope to learn more about ribociclib to help future patients with advanced breast cancer.

Key takeaways

  • This study is for women with advanced HR+/HER2- breast cancer.
  • Participants will receive ribociclib and standard hormone therapy as their first treatment.
  • Researchers want to understand how well ribociclib works and why, looking at both survival and quality of life.
  • Detailed samples (like blood) will be collected to find biological clues (biomarkers).
  • It's a 'Phase 4' study, meaning the drug is already approved.
  • Your participation could help improve future treatments for breast cancer.

Who may be eligible?

This study is looking for women aged 18 or over who have advanced breast cancer that has specific characteristics: it must be 'hormone receptor-positive' (meaning it responds to hormones) and 'HER2-negative' (meaning it doesn't have too much of a protein called HER2). You must be suitable to start treatment with ribociclib and standard hormone therapy for your advanced breast cancer as your very first treatment.

There are also some health requirements, such as having good organ function and a normal heart rhythm. If you are able to have children, you would need to use effective contraception during the study and for a short time afterwards. You also need to be willing to come for all your appointments and follow the study instructions.

You wouldn't be able to join if you are already taking part in another study with an experimental drug, if your breast cancer doesn't fit the specific HR+/HER2- type being studied, or if your doctor doesn't think ribociclib is the right treatment for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman aged 18 or over?
  2. Do you have advanced breast cancer that is 'hormone receptor-positive' and 'HER2-negative'?
  3. Are you about to start ribociclib and hormone therapy as your very first treatment for advanced breast cancer?
  4. Are you willing and able to attend all study appointments and provide samples?
  5. Are you currently not taking part in another clinical trial with an experimental drug?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the drug ribociclib along with standard hormone therapy, just as your doctor would normally prescribe it. You would need to attend regular clinic appointments for check-ups, assessments, and to provide various samples (like blood or tissue biopsies). These samples will help researchers understand how the treatment works at a very detailed level. These visits would happen before, during, and after your treatment, or if your cancer changes. The total duration of your participation would depend on your treatment plan and how your cancer responds, but it would involve regular follow-up visits over a period of time.

Potential risks and benefits

Potential benefits of taking part include receiving ribociclib and standard hormone therapy under close medical supervision, which might offer further insights into your treatment. Your participation will also help researchers learn more about breast cancer and ribociclib, which could benefit future patients. As with any medication, there are potential side effects associated with ribociclib and hormone therapy, and these will be carefully monitored. You will be told about all known risks before you decide to join. Remember, taking part in any study is entirely voluntary, and you can withdraw at any time without affecting your medical care.

Locations (52)

  • Department of Gynecology and Obstetrics, Erlangen University Hospital
    Verified postcode
    Erlangen, Germany· Recruiting
  • Department of Gynecology and Obstetrics, University Medicine Mainz
    City only
    Mainz, Germany· Recruiting
  • Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
    Verified postcode
    Bottrop, Germany· Recruiting
  • Klinikum St Marien Amberg
    Verified postcode
    Amberg, Germany· Recruiting
  • Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
    Verified postcode
    Aschaffenburg, Germany· Recruiting
  • Klinik für Hämatologie und Onkologie, Uniklinik Augsburg
    Verified postcode
    Augsburg, Germany· Not yet recruiting
  • University Hospital Augsburg
    Verified postcode
    Augsburg, Germany· Recruiting
  • Frauenklinik des Klinikums Bamberg
    Verified postcode
    Bamberg, Germany· Not yet recruiting
  • MediOnko GbR
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • HELIOS Klinikum Berlin-Buch
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik
    Verified postcode
    Bonn, Germany· Not yet recruiting
  • Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte
    Verified postcode
    Bremen, Germany· Not yet recruiting

Common questions

What is ribociclib?

Ribociclib is a medicine used to treat a specific type of advanced breast cancer.

What does HR+/HER2- mean?

It describes a type of breast cancer that is positive for hormone receptors and negative for another protein called HER2.

Will I get special treatment in this study?

You will receive ribociclib and standard hormone therapy, as your doctor would typically prescribe. The study mainly involves extra tests and samples for research.

What are 'biomarkers'?

Biomarkers are tiny clues in your body (like in blood or tissue) that can help researchers understand how a treatment might work for you.

Is this a new drug?

No, ribociclib is already an approved drug. This study is gathering more information about its use in the real world.

How to find out more

CAPTOR Study Manager

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Comprehensive Analysis of Spatial, Temporal and Molecular Pa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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