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Abemaciclib for Older Patients with Breast Cancer
Study Summary
This trial looks at abemaciclib as a possible treatment for breast cancer in patients age 70 and older.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT02102490Trial Design
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Who is running the clinical trial?
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- I am not taking any medications that are not allowed in the study.I have a digestive issue that affects how I absorb medication.Your platelet count is at least 100 billion per liter.I do not have any ongoing serious infections.My cancer can be measured by tests or seen on scans.I can read and understand either English or Spanish.You are expected to live for at least 6 more months.My kidneys are functioning well enough, as shown by a test.Your bilirubin levels must be within a certain range, unless you have Gilbert's syndrome, in which case there is a different range for your direct bilirubin levels.I do not have any serious or uncontrolled health conditions.My brain and spinal cord are not affected by my cancer, or they meet certain conditions.I do not have any severe health conditions that would make treatment unsafe for me.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.My cancer has worsened despite previous treatments.I am not using herbal medications during the trial.I've recovered from major side effects of my last chemotherapy, with at least 3 weeks since my last dose.You are taking medication that could affect the study results.You are allergic to any of the ingredients in abemaciclib.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I cannot swallow pills.Your ANC (absolute neutrophil count) is equal to or greater than 1.5 X 10^9/L.Your hemoglobin level is at least 8 grams per deciliter.Your liver function tests should be within a certain range, unless you have cancer that has spread to the liver.I haven't had major surgery in the last 2 weeks or still recovering from one.I am 70 years old or older.My breast cancer has spread and this was confirmed by imaging tests.My breast cancer is positive for estrogen and/or progesterone receptors.I do not have lung inflammation or scarring.My breast cancer is HER2-negative according to specific tests.I was diagnosed with another cancer within the last 2 years and it's still present.
- Group 1: Treatment (abemaciclib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Abemaciclib received confirmation from the FDA?
"Abemaciclib was ranked a 2 on our safety scale due to the absence of efficacy data, though clinical studies have been conducted to assess its security."
Is this empirical research pioneering in nature?
"Presently, Abemaciclib is the subject of 92 running trials across 1276 municipalities and 41 nations. Since its initial trial in 2009 (conducted by Eli Lilly & Co., with 220 participants for Phase 1 drug approval) 209 studies have been carried out."
What indications are most often linked to Abemaciclib administration?
"Abemaciclib can be employed to address high-risk cases of recurrent, advanced HR+/HER2- breast cancer and endocrine therapy."
Is enrollment still open for this experiment?
"Clinicaltrials.gov confirms that this medical trial is currently enlisting study participants; it was first announced on March 25th 2020 and the most recent update came out November 1st 2022."
How many participants have been recruited for this research project?
"Affirmative. The details found on clinicaltrials.gov verify that this medical investigation is actively recruiting participants, having first been posted in March of 2020 and edited most recently in November 2022. In total, 40 individuals are needed to be recruited from one site."
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