Optimizing CDK 4/6-inhibitor doses for older breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on older patients (70 years and above) with advanced hormone receptor-positive and HER2-negative breast cancer who are not candidates for curative treatment. It employs a multicenter, open-label, randomized-controlled design to assess the effectiveness of a comprehensive geriatric assessment (CGA) in determining the appropriate dosing of CDK 4/6-inhibitors combined with endocrine therapy. The goal is to evaluate whether a personalized dosing strategy based on CGA can improve treatment outcomes compared to standard dose reduction practices. Patients will be randomized to receive either the full dose or a reduced dose of the medication based on their CGA results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The following inclusion criteria will be applied:

1. Patients male or female aged at least 70 years old at the time of informed consent.
2. Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory.
3. Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.
4. No prior systemic treatment for advanced disease (recurrence during neo-/adjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4/6-inhibitor initiation is allowed.
5. Adjuvant treatment with CDK 4/6-inhibitors is allowed provided a disease-free interval from treatment end \>12 months.
6. Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1.
7. Written informed consent prior to any study-specific procedures.
8. Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4/6-inhibitors that is planned to be used.
9. Able to swallow capsules.
10. Able to understand and consent in English language or in native language for each participating country.

Exclusion Criteria:

Eligible patients will be excluded if they have one of the following criteria:

1. Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors.
2. Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.
3. Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.
4. History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
5. Participating in other interventional trial.

Where it's running

• Department of Oncology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki
  Helsinki, Finland Recruiting
• Department of Oncology, Örebro University Hospital
  Örebro, Sweden Recruiting
• Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital
  Athens, Greece Not yet recruiting
• Second Department of Medical Oncology, Hygeia Hospital
  Athens, Greece Not yet recruiting
• Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School
  Pátrai, Greece Not yet recruiting
• Medical Oncology Unit, S. Andrew Hospital
  Pátrai, Greece Not yet recruiting

Study contacts

• Study coordinator: Antonios Valachis, Assoc Prof
• Email: important@oru.se
• Phone: +46196021792

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.