Study on CDK4/6 Inhibitor Dosing for Older Patients with Metastatic Breast Cancer
Sponsor: American Society of Clinical Oncology
ClinicalTrials ID:NCT06377852
This clinical trial is exploring a new dosing strategy for CDK4/6 inhibitors to help patients aged 65 and older with metastatic breast cancer manage side effects better and stay on treatment longer.
Patient Parameters
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Program Overview
The study aims to find out if starting CDK4/6 inhibitors at a lower dose and gradually increasing it can help older patients with metastatic breast cancer tolerate the treatment better and continue it for a longer time. This approach will be compared to the standard dosing, which starts at a higher dose. Participants will choose between two CDK4/6 inhibitors, palbociclib or ribociclib, and an endocrine therapy, either an aromatase inhibitor or fulvestrant, with their doctor. They will then be randomly assigned to either the standard dosing group or the lower, gradually increasing dosing group.
Description
The CDK4/6 Inhibitor Dosing Knowledge Study is designed for patients aged 65 or older with metastatic breast cancer. The goal is to compare two dosing strategies for CDK4/6 inhibitors: the standard dosing, which starts at the full dose, and a new approach that starts at a lower dose and increases if tolerated. This study will help determine which method allows patients to stay on treatment longer and manage side effects better. Participants will work with their doctor to choose a CDK4/6 inhibitor (palbociclib or ribociclib) and an endocrine therapy (aromatase inhibitor or fulvestrant). They will then be randomly assigned to one of the dosing strategies. The main focus is on how long patients can continue the treatment. The study will also look at how different factors, like age and health status, affect treatment outcomes. By including a wide range of participants, the study aims to provide insights that can help personalize treatment for older adults with metastatic breast cancer.
Eligibility Criteria
Inclusion Criteria
- Have hormone receptor positive (HR+) HER2 negative metastatic breast cancer.
- Be a candidate for endocrine therapy combined with palbociclib or ribociclib for the first time in the metastatic setting.
- Be 65 years or older.
- Have adequate bone marrow and organ function, including:
- Neutrophil count of at least 1,000/µL.
- Platelet count of at least 100,000/µL.
- Hemoglobin level of at least 9g/dL.
- Total bilirubin within 1.5 times the normal limit (up to 5 times for those with Gilbert's disease).
- Liver enzymes (AST/ALT) within 3 times the normal limit, or 5 times for those with liver metastases.
- Normal creatinine levels or creatinine clearance of at least 30 mL/min/1.73 m2.
- Baseline QTc of 480 ms or less (for ribociclib patients).
- Be able to understand and sign a consent form.
Exclusion Criteria
- Have previously been treated with a CDK4/6 inhibitor for metastatic breast cancer, or within the past year for early breast cancer.
- Have used the planned endocrine therapy for more than 30 days.
- Have a known allergy or intolerance to the study drugs.
- Have an uncontrolled illness that would interfere with the study.
- Be receiving other investigational treatments.
- Have rapidly progressing brain metastases.
- Have active or chronic Hepatitis B or C, unless liver function is adequate and there are no drug interactions.
- Be using drugs that prolong the QT interval.
- Have other cancers that are currently being treated.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer & Research Centers | 85224 | Chandler | Arizona |
| Ironwood Cancer & Research Centers | 85297 | Gilbert | Arizona |
| Ironwood Cancer & Research Centers | 85306 | Glendale | Arizona |
| Ironwood Cancer & Research Centers | 85202 | Mesa | Arizona |
| Ironwood Cancer & Research Centers | 85206 | Mesa | Arizona |
| Ironwood Cancer & Research Centers | 85028 | Phoenix | Arizona |
| Ironwood Cancer & Research Centers | 85260 | Scottsdale | Arizona |
| Smilow Cancer Hospital Care Center - Derby | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center - Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital at Glastonbury | 06033 | Glastonbury | Connecticut |
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