Study on Abemaciclib and Hormone Therapy for Older Patients with Breast Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT04305834
This clinical trial is exploring the side effects of the drug abemaciclib in patients aged 70 and older who have hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body.
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Program Overview
The purpose of this study is to understand the side effects of using abemaciclib alone in treating older adults with a specific type of breast cancer that has spread. The study will look at how often severe side effects occur and will also track other side effects, treatment changes, and how well patients stick to the treatment plan. Participants will take abemaciclib pills twice a day in 28-day cycles, as long as the cancer does not worsen or side effects are manageable. After finishing the treatment, patients will have follow-up visits for up to two years.
Description
The main goal of this study is to find out how often severe side effects happen when using abemaciclib alone in patients aged 70 or older with hormone receptor-positive metastatic breast cancer. The study will also look at all side effects, including those reported by patients, and track any changes in treatment, such as dose reductions or stopping treatment due to reasons other than cancer progression. Researchers will measure how long patients live without the cancer getting worse and overall survival rates. They will also use questionnaires to understand patients' views on the treatment's worth and overall usefulness. The study will monitor how well patients follow the treatment plan and measure the drug levels in their blood. Additionally, researchers will explore the relationship between aging biomarkers and severe side effects. Participants will take abemaciclib pills twice daily for 28-day cycles, continuing as long as the cancer does not progress or side effects are tolerable. After completing the treatment, patients will have follow-up visits at 30 days, then every six months for two years.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate
- Age 70 years or older
- Life expectancy greater than 6 months
- Ability to read and understand English or Spanish
- Have measurable or non-measurable disease
- Diagnosed with estrogen-receptor positive and/or progesterone receptor positive breast cancer
- HER2-negative breast cancer
- Have metastatic breast cancer confirmed by scans
- Cancer has progressed after previous hormone therapy or certain cancer drugs
- Recovered from side effects of previous cancer treatments
- No active central nervous system involvement unless specific criteria are met
- No interstitial lung disease or pneumonitis
- Adequate blood cell counts and organ function as determined by specific tests
- Creatinine clearance of 30 mL/min or higher
Exclusion Criteria
- Major surgery within 14 days before starting the study drug
- Currently taking prohibited medications that cannot be stopped 7 days before starting the study drug
- Known allergy to abemaciclib ingredients
- Active bacterial, fungal, or viral infections
- Gastrointestinal issues that may affect drug absorption
- History of certain heart conditions
- Other severe or uncontrolled medical conditions
- Inability to swallow pills
- Serious preexisting medical conditions that would prevent participation
- History of non-compliance with medical treatment
- Prior cancer diagnosis within 2 years with evidence of disease, except for certain skin or cervical cancers
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