Abemaciclib for Older Patients with Breast Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: City of Hope Medical Center
Must not be taking: Immune-suppressive, Herbal medications
Disqualifiers: Major surgery, Active infections, GI impairment, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as other investigational therapies, anticancer agents not part of the study, immune-suppressive agents, and herbal medications, at least 7 days before starting the study drug. It's best to discuss your current medications with the trial team to see if any need to be stopped.
What data supports the effectiveness of the drug Abemaciclib for older patients with breast cancer?
Research shows that Abemaciclib, when combined with hormone therapy, reduces the risk of breast cancer coming back in patients with certain types of early breast cancer. It has been effective in both premenopausal and postmenopausal patients, and it helps improve the time patients live without the cancer getting worse.
12345Is Abemaciclib safe for humans?
Abemaciclib has been studied in various clinical trials and is generally considered safe when used with other therapies for breast cancer, though it can cause side effects like diarrhea, infections, and neutropenia (low white blood cell count).
23467How is the drug Abemaciclib different from other treatments for breast cancer?
Abemaciclib is unique because it is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, which helps stop cancer cells from growing by blocking specific proteins involved in cell division. It is used in combination with endocrine therapy for patients with hormone receptor-positive, HER2-negative breast cancer, particularly those at high risk of recurrence, and has shown to reduce the risk of cancer returning compared to endocrine therapy alone.
23789Eligibility Criteria
This trial is for patients aged 70 or older with hormone receptor positive, HER2 negative metastatic breast cancer who have progressed on prior treatments. They must have recovered from previous therapies' side effects and not have certain infections, severe medical conditions, or a history of non-compliance to medical regimens.Inclusion Criteria
Your platelet count is at least 100 billion per liter.
My cancer can be measured by tests or seen on scans.
I can read and understand either English or Spanish.
+16 more
Exclusion Criteria
History of non-compliance to medical regimen
I am not taking any medications that are not allowed in the study.
I have a digestive issue that affects how I absorb medication.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive abemaciclib orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Up to 6 cycles (24 weeks)
Monthly visits for each cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Every 6 months
Participant Groups
The study tests the safety of abemaciclib monotherapy in elderly patients with advanced breast cancer. It's a phase IIa trial focusing on those who've had other treatments before. Participants will also complete questionnaires as part of the study.
1Treatment groups
Experimental Treatment
Group I: Treatment (abemaciclib)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Abemaciclib is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Verzenio for:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
🇪🇺 Approved in European Union as Verzenio for:
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
Dana Farber Cancer InstituteBoston, MA
Roswell Park Comprehensive Cancer CenterBuffalo, NY
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
An UHPLC-MS/MS method for quantification of the CDK4/6 inhibitor abemaciclib in human serum. [2022]Abemaciclib is a new oral targeted treatment option for patients with advanced breast cancer. The emerging field of oral antitumor therapeutics presents challenges for both patients and healthcare teams; non-adherence and high inter-individual pharmacokinetic variability can influence response rates.
Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. [2023]Abemaciclib was recently approved by the European Medicines Agency in combination with adjuvant endocrine therapy (ET) for adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), node-positive early breast cancer (EBC) at high risk of recurrence.
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]Abemaciclib [Verzenio® (USA) or Verzenios® (EU)] is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor approved in combination with adjuvant endocrine therapy for patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), node-positive, early breast cancer with a high risk of recurrence. In a phase III trial, abemaciclib plus endocrine therapy reduced the risk of recurrence of breast cancer compared with endocrine therapy alone, including in patients who had previously received neoadjuvant chemotherapy, in patients with high- and low-scoring Ki-67 tumours, and in both premenopausal and postmenopausal patients. The tolerability profile of abemaciclib plus endocrine therapy was acceptable and manageable, with diarrhoea, infections and neutropenia being the most common adverse events. Thus, abemaciclib in combination with standard endocrine therapy is a valuable additional treatment option for patients with HR+, HER2-, node-positive early breast cancer with a high risk of recurrence.
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]Interim data from the MONARCH3 study indicate that abemaciclib is an effective first-line therapy for advanced ER-positive, HER2-negative breast cancer. Adding the investigational CDK4/6 inhibitor to letrozole significantly improved patients' progression-free survival, compared with those given a placebo alongside endocrine therapy.
Feasibility of Adjuvant Treatment with Abemaciclib-Real-World Data from a Large German Breast Center. [2022]Abemaciclib significantly improves invasive disease-free survival when combined with endocrine therapy in clinical high-risk patients with HR+/Her2- early breast cancer (eBC). The objective of the following study was to model how many patients with eBC would be available for adjuvant treatment with abemaciclib in a real-world setting. Patients that underwent complete surgical treatment for eBC between January 2018 and December 2020 in a large single-center university hospital in Germany were eligible. Descriptive statistics were used to describe the patient population that could benefit from abemaciclib according to the inclusion criteria of monarchE. Of 1474 patients with eBC, 1121 (76.1%) had a HR+/Her2- subtype. Of these, 217 (19.4%) fulfilled the monarchE inclusion criteria. Within patients that fulfilled the monarchE inclusion criteria, 48.9% received no adjuvant or neoadjuvant chemotherapy. Thus, in a real-world situation, fewer patients will be pretreated with chemotherapy than was the case in monarchE. Breast care units are facing a significant patient burden, since the 2-year abemaciclib therapy requires regular monitoring of toxicities. Specific care concepts to strengthen therapy adherence as well as further studies to deescalate adjuvant systemic treatment and individualize CDK 4/6 inhibitor therapy are therefore needed.
Abemaciclib: First Global Approval. [2019]Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. In addition, abemaciclib is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of abemaciclib leading to its first approval for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Abemaciclib: The Newest CDK4/6 Inhibitor for the Treatment of Breast Cancer. [2020]To review the pharmacology, efficacy, and safety of the cyclin-dependent kinase (CDK) inhibitor, abemaciclib, in the treatment of advanced or metastatic breast cancer (MBC).
[Development of CDK4 & 6 Inhibitor Abemaciclib in Breast Cancer]. [2021]Abemaciclib is a selective cyclin-dependent kinase(CDK)4 & 6 inhibitor, which induces G1 cell cycle arrest and tumour growth inhibition. Abemaciclib has been developed for use in hormone receptor positive(HR+)breast cancer, dosed daily in combination with endocrine therapy. In a phase Ⅲ clinical trial, MONARCH 2, for women with HR+ and human epidermal growth factor receptor 2 negative(HER2-)advanced breast cancer who progressed after endocrine therapy, abemaciclib in combination with fulvestrant significantly improved not only progression-free survival and objective response rate but also overall survival, and demonstrated a tolerable safety profile. Another phase Ⅲ clinical trial, MONARCH 3, for women with HR+ and HER2- advanced breast cancer, abemaciclib in combination with nonsteroidal aromatase inhibitor as an initial therapy also significantly improved progression-free survival and objective response rate. This review presents the rationale for the use of CDK4 & 6 inhibitors in the treatment of breast cancer, background on the development of abemaciclib, clinical data focusing on phase Ⅲ studies of abemaciclib, and information on ongoing clinical studies of abemaciclib.
Efficacy and safety results by menopausal status in monarchE: adjuvant abemaciclib combined with endocrine therapy in patients with HR+, HER2-, node-positive, high-risk early breast cancer. [2023]Abemaciclib is the first and only cyclin-dependent kinases 4 and 6 inhibitor approved for adjuvant treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, and high-risk early breast cancer (EBC), with indications varying by geography. Premenopausal patients with HR+, HER2- tumors may have different tumor biology and treatment response compared to postmenopausal patients.