CDK4/6 Inhibitors for Metastatic Breast Cancer

CDK4 and CDK6 are enzymes important in cell division. CDK4/6 inhibitors are drugs designed to interrupt the growth of cancer cells.

CDK4/6 inhibitors are used in combination with hormone therapy to treat some hormone receptor-positive breast cancers.

The CDK4/6 inhibitors FDA-approved for metastatic breast cancer treatment are:

Drug name

Brand name

How is it given?

Abemaciclib

Verzenio

Pill

Palbociclib

Ibrance

Pill

Ribociclib

Kisqali

Pill

Although the CDK4/6 inhibitors abemaciclib, palbociclib and ribociclib have not been compared directly to one another, studies show similar results with each drug in treating metastatic breast cancer [6-14].

CDK4/6 inhibitors and metastatic breast cancer treatment

CDK4/6 inhibitors are used in combination with hormone therapy (an aromatase inhibitor or fulvestrant).

A CDK4/6 inhibitor in combination with hormone therapy can be used to treat some metastatic breast cancers that are:

Compared to treatment with hormone therapy alone, the combination of hormone therapy and a CDK4/6 inhibitor can give people more time before the cancer spreads and increase overall survival [6-14].

The CDK4/6 inhibitor abemaciclib may also be used alone to treat hormone receptor-positive, HER2-negative cancers that have progressed on past hormone therapy and chemotherapy [4].

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For a summary of research studies on CDK4/6 inhibitors and metastatic breast cancer treatment, visit the Breast Cancer Research Studies section.

Learn more about hormone therapy in the treatment of metastatic breast cancer.

Learn more about treatment for metastatic breast cancer.

Learn more about emerging areas in treatment for metastatic breast cancer.

Learn about the CDK4/6 inhibitor abemaciclib in the treatment of early breast cancer.

How are CDK4/6 inhibitors given?

The CDK4/6 inhibitors abemaciclib, palbociclib and ribociclib are pills.

Side effects of CDK4/6 inhibitors

The table below lists some possible side effects of CDK4/6 inhibitors.

CDK4/6 Inhibitor

Side Effects

Abemaciclib

Possible side effects include diarrhea, low white blood cell counts, anemia (low red blood cell counts), blood clots, nausea, abdominal pain, fatigue and vomiting.

In some cases, it can cause liver problems. Your liver function will be checked before treatment begins and throughout your treatment.

In rare cases, it can cause lung inflammation, which can lead to death. Tell your health care provider right away if you have shortness of breath or other breathing problems while taking this drug.

Palbociclib

Possible side effects include low white blood cell counts, anemia (low red blood cell counts), fatigue, nausea, mouth sores, hair thinning, diarrhea and in rare cases, blood clots.

In rare cases, it can cause lung inflammation, which can lead to death. Tell your health care provider right away if you have shortness of breath or other breathing problems while taking this drug.

Ribociclib

Possible side effects include low white blood cell counts, nausea, fatigue, diarrhea, hair loss, vomiting, constipation, headache and back pain.

In some cases, it can cause liver problems. Your liver function will be checked before treatment begins and throughout your treatment.

In rare cases, it can cause changes on an EKG (electrocardiogram). An EKG gives information on the electrical activity of the heart. You will get an EKG before treatment begins and throughout your treatment to check for any changes.

In rare cases, it can cause lung inflammation, which can lead to death. Tell your health care provider right away if you have shortness of breath or other breathing problems while taking this drug.

Adapted from select sources [6-17].

 

Monitoring metastatic breast cancer

You’ll be monitored (checked) regularly with scans to see if the cancer is responding to treatment. If it’s no longer working, or if the side effects are not manageable, your health care provider will change your treatment.

Learn more about how metastatic breast cancer is monitored.

Clinical trials

Clinical trials offer the chance to try new treatments and possibly benefit from them.

Consider joining a clinical trial when your oncologist is considering changing treatments, before starting a new treatment or when there are limited treatment options.

Susan G. Komen® Breast Care Helpline

If you or a loved one needs information or resources about clinical trials, call the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email clinicaltrialinfo@komen.org.

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Metastatic Trial Search

The Metastatic Trial Search is a web-based clinical trial matching tool that can help you find clinical trials that fit your needs.

Learn more about clinical trials for people with metastatic breast cancer.

Prescription drug assistance

The cost of drug therapies for metastatic breast cancer can quickly become a financial burden for you and your family.

Medicare and many insurance companies offer prescription drug plans. One may already be included in your policy, or you may be able to buy an extra plan for prescriptions.

Some drugs are off-patent and may have a generic form. Generic drugs cost less than the name brands but are just as effective.

You may also qualify for programs that help with drug costs or offer low-cost or free prescriptions.

Learn more about insurance plans and prescription drug assistance programs.

Learn more about other financial assistance programs.

Komen Financial Assistance Program

Susan G. Komen® created the Komen Financial Assistance Program to help those struggling with the costs of breast cancer treatment by providing financial assistance to eligible individuals.

Funding is available for eligible individuals undergoing breast cancer treatment at any stage or living with metastatic breast cancer (stage IV).

To learn more about this program and other helpful resources, call the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877-465-6636) or email helpline@komen.org.

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Susan G. Komen®‘s position on fairness in oral cancer drug coverage

Insurance coverage of oral cancer drugs

Cancer medications given by vein (through an IV) or injection (under the skin or into a muscle) are usually covered under a health insurance plan’s medical benefit. However, cancer medications that are pills (oral cancer drugs) are usually covered under a health insurance plan’s prescription drug benefit.

As a result, people often find themselves facing high out-of-pocket costs when filling prescriptions for oral cancer drugs. Sometimes these costs can be thousands of dollars a month.

The impact of high cost-sharing

High prescription drug costs and the resulting out-of-pocket burden on patients are a barrier to care. They can prevent people from getting the medications prescribed by their health care providers.

No one should be forced to get less appropriate treatment because an insurer gives more coverage for IV and injectable drugs than pills.

Efforts to increase fairness in drug coverage

Komen supports state and federal efforts to require insurers to provide the same or better coverage for oral cancer drugs as they do for IV and injectable cancer drugs. This would help make sure patients have access to affordable, appropriate treatment.

Become a Komen Advocacy Insider

Sign up to be a Komen Advocacy Insider and get informed when action is needed on drug coverage issues at the state or national level.

SUSAN G. KOMEN® SUPPORT RESOURCES

  • If you or a loved one needs more information about breast health or breast cancer, contact the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877-465-6636) or email helpline@komen.org. All calls are answered by a trained specialist or oncology social worker, Monday through Friday from 9:00 a.m. to 10:00 p.m. ET. Se habla español.
  • Komen Patient Navigators can help guide you through the health care system as you go through a breast cancer diagnosis. They can help to remove barriers to high-quality breast care. For example, they can help you with insurance, local resources, communication with health care providers and more. Call the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877-465-6636) or email helpline@komen.org to learn more about our Patient Navigator program, including eligibility.
  • We offer an online support community through our closed Komen Metastatic Breast Cancer group. The Facebook group provides a place where those living with metastatic breast cancer, and those who love them, can find support, friendship and information. Visit Facebook, search for Komen Metastatic Breast Cancer (Stage IV) Group and request to join the closed group.
  • Our free MBC Impact Series provides people living with metastatic breast cancer and their loved ones a safe, collaborative space to gather information related to MBC and discover practical resources to help make decisions for improved physical and emotional health. To learn more and register visit www.komen.org/mbcseries.
  • Our podcast series Real Pink covers many relevant topics for people living with metastatic breast cancer and caregivers.
  • Our fact sheets, booklets and other education materials offer additional information.
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*Please note, the information provided within Komen Perspectives articles is only current as of the date of posting. Therefore, some information may be out of date.

Updated 10/05/22

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