Status:
RECRUITING
Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients
Lead Sponsor:
Region Örebro County
Collaborating Sponsors:
University of Patras
University of Florence
Conditions:
Metastatic Breast Cancer
Advanced Breast Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief 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 recept...
Eligibility Criteria
Inclusion
- The following inclusion criteria will be applied:
- Patients male or female aged at least 70 years old at the time of informed consent.
- 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.
- Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.
- 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.
- Adjuvant treatment with CDK 4/6-inhibitors is allowed provided a disease-free interval from treatment end \>12 months.
- Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1.
- Written informed consent prior to any study-specific procedures.
- Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4/6-inhibitors that is planned to be used.
- Able to swallow capsules.
- Able to understand and consent in English language or in native language for each participating country.
Exclusion
- Eligible patients will be excluded if they have one of the following criteria:
- Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors.
- Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.
- Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.
- 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.
- Participating in other interventional trial.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT06044623
Start Date
April 1 2024
End Date
May 31 2029
Last Update
November 19 2024
Active Locations (12)
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1
Department of Oncology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki
Helsinki, Finland
2
Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital
Athens, Greece
3
Second Department of Medical Oncology, Hygeia Hospital
Athens, Greece
4
Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School
Pátrai, Greece