Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

Last updated: November 15, 2024
Sponsor: Region Örebro County
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Metastatic Cancer

Adverse Effects, Drugs

Treatment

CDK 4/6 inhibitors

Endocrine therapy

Clinical Study ID

NCT06044623
280232
  • Ages > 70
  • All Genders

Study Summary

IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.

On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.

This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.

Eligibility Criteria

Inclusion

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 asestrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of themost recent tumor specimen by local laboratory.

  3. Advanced (locoregionally recurrent or metastatic) breast cancer not amenable tocurative treatment.

  4. No prior systemic treatment for advanced disease (recurrence during neo-/adjuvantendocrine therapy is allowed). A prior period of treatment with aromatase inhibitorsor 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-freeinterval from treatment end >12 months.

  6. Either measurable disease or non-measurable bone only disease, but evaluableaccording 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 eachparticipating country.

Exclusion

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 beused.

  3. Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningealcarcinomatosis.

  4. History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situof the cervix), unless in complete remission with no therapy for a minimum of 3years.

  5. Participating in other interventional trial.

Study Design

Total Participants: 495
Treatment Group(s): 2
Primary Treatment: CDK 4/6 inhibitors
Phase: 3
Study Start date:
April 01, 2024
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • Department of Oncology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki

    Helsinki,
    Finland

    Active - Recruiting

  • Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital

    Athens,
    Greece

    Site Not Available

  • Second Department of Medical Oncology, Hygeia Hospital

    Athens,
    Greece

    Site Not Available

  • Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School

    Patras,
    Greece

    Site Not Available

  • Medical Oncology Unit, S. Andrew Hospital

    Patras,
    Greece

    Site Not Available

  • Second Department of Medical Oncology, Euromedica General Clinic

    Thessaloníki,
    Greece

    Site Not Available

  • Radiation Oncology Unit - Oncology Department, Azienda Ospedaliero Universitaria Careggi

    Florence,
    Italy

    Site Not Available

  • "Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato

    Prato,
    Italy

    Site Not Available

  • Department of Oncology, Akershus University Hospital (AHUS)

    Oslo,
    Norway

    Site Not Available

  • Department of Medical Oncology, Hospital Clinic of Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Department of Oncology, Uppsala University Hospital

    Uppsala, 75185
    Sweden

    Site Not Available

  • Department of Oncology, Örebro University Hospital

    Örebro,
    Sweden

    Active - Recruiting

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