43 Participants Needed

Abemaciclib for Older Patients with Breast Cancer

Recruiting at 2 trial locations
JM
Overseen ByJoanne Mortimer, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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).23467

How 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.23789

Research Team

Joanne Mortimer, M.D., F.A.C.P., F.A.S ...

Joanne E Mortimer, MD

Principal Investigator

City of Hope Medical Center

Eligibility 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.
See 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.
See 11 more

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

Treatment Details

Interventions

  • Abemaciclib
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

A new ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method was developed to effectively monitor abemaciclib levels in patients with advanced breast cancer, showing high accuracy and precision in quantification.
This method allows for robust therapeutic drug monitoring (TDM) of abemaciclib, which can help personalize treatment and improve adherence in patients, addressing challenges in the emerging field of oral antitumor therapies.
An UHPLC-MS/MS method for quantification of the CDK4/6 inhibitor abemaciclib in human serum.Habler, K., Vogeser, M., Teupser, D.[2022]
Abemaciclib combined with endocrine therapy (ET) significantly improves quality-adjusted life years (QALYs) in patients with high-risk hormone receptor positive, HER2-negative early breast cancer, with an increase of 0.99 QALYs compared to ET alone.
The treatment is considered cost-effective in Italy, with an incremental cost-effectiveness ratio of €22,651 per QALY gained, and a 99% likelihood of being cost-effective at a threshold of €30,000 per QALY.
Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy.Davie, A., Traoré, S., Giovannitti, M., et al.[2023]
In a phase III trial, abemaciclib combined with endocrine therapy significantly reduced the risk of breast cancer recurrence in patients with hormone receptor positive (HR+), HER2-negative, node-positive early breast cancer, regardless of prior chemotherapy or tumor characteristics.
The combination treatment was generally well-tolerated, with manageable side effects such as diarrhea, infections, and neutropenia, making it a valuable option for high-risk patients.
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence.Fung, S., Blair, HA.[2023]

References

An UHPLC-MS/MS method for quantification of the CDK4/6 inhibitor abemaciclib in human serum. [2022]
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: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
First-Line Abemaciclib Effective in ER+ Breast Cancer. [2019]
Feasibility of Adjuvant Treatment with Abemaciclib-Real-World Data from a Large German Breast Center. [2022]
Abemaciclib: First Global Approval. [2019]
Abemaciclib: The Newest CDK4/6 Inhibitor for the Treatment of Breast Cancer. [2020]
[Development of CDK4 & 6 Inhibitor Abemaciclib in Breast Cancer]. [2021]
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]