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

Launched by REGION ÖREBRO COUNTY · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial, called the IMPORTANT study, is exploring how to better treat older patients (aged 70 and up) with advanced breast cancer that is not curable. Specifically, the trial is looking at a type of medication called CDK 4/6 inhibitors, used alongside hormone therapy. The researchers want to see if starting treatment with a lower dose of these medications is effective for older patients who may be more vulnerable to side effects, compared to giving the full dose. To help decide the best treatment plan for each patient, doctors will conduct a comprehensive geriatric assessment that evaluates their overall health and ability to tolerate the medication.

To be eligible for this trial, participants must be at least 70 years old and have a specific type of breast cancer that is advanced but not able to be cured. They should not have received prior treatment for their advanced cancer, although some earlier treatments are allowed as long as a certain amount of time has passed. Throughout the trial, participants can expect close monitoring and support as they receive the assigned treatment. This study is important because it aims to personalize cancer treatment for older patients, ensuring they receive the safest and most effective care possible.

Gender

ALL

Eligibility criteria

• 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.