CDK4/6 Inhibitors
Watch our Breast Cancer Breakthrough series episode 9, “New Frontiers in Early ER-positive Breast Cancer” and for more information on the clinical trial discussed, read our Breakthroughs fact sheet.
What are CDK4/6 inhibitors?
Cyclin-dependent kinase 4 and 6 (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 pills that are used in combination with hormone therapy to treat some hormone receptor-positive breast cancers.
Drug name |
Brand name |
Used to treat early or metastatic breast cancer? |
Abemaciclib |
Verzenio |
Early and metastatic breast cancer |
Ribociclib |
Kisqali |
Early and metastatic breast cancer |
Palbociclib |
Ibrance |
Metastatic breast cancer |
Learn about CDK4/6 inhibitors and metastatic breast cancer treatment.
Watch our video to learn how CDK4/6 inhibitors work with hormone therapy to treat breast cancer.
Abemaciclib and ribociclib for early breast cancer treatment
Abemaciclib (Verzenio) and ribociclib (Kisqali) are CDK4/6 inhibitor drugs. They are given in combination with hormone therapy to treat some hormone receptor-positive, HER2-negative breast cancers.
The randomized clinical trials that led to the FDA approval of abemaciclib and ribociclib enrolled slightly different participants. While the FDA approval is similar for each drug, there are some differences [139,332].
Abemaciclib |
Ribociclib |
Hormone receptor-positive |
Hormone receptor-positive |
HER2-negative |
HER2-negative |
Lymph node-positive or lymph node-negative |
|
At high risk of recurrence |
At high risk of recurrence |
Findings from randomized clinical trials show hormone therapy plus abemaciclib or ribociclib may reduce the risk of breast cancer recurrence better than hormone therapy alone in people with hormone receptor-positive, HER2-negative breast cancers at high risk of recurrence [140,319].
Abemaciclib can only be used to treat lymph node-positive breast cancer (4 or more positive nodes, or 1-3 positive nodes and also have other high-risk features) [139].
Ribociclib can be used to treat lymph node-positive breast cancers, and can also treat lymph node-negative breast cancers that have other high-risk features [332].
In the randomized clinical trials of abemaciclib and ribociclib, most people already got chemotherapy for early breast cancer (about 90% to 95%) [140,319].
| For a summary of research studies on CDK4/6 inhibitors and early breast cancer treatment, visit the Breast Cancer Research Studies section. |
How are abemaciclib and ribociclib given?
Abemaciclib
Abemaciclib is a pill taken twice a day for 2 years. It’s given in combination with tamoxifen or an aromatase inhibitor.
Ribociclib
Ribociclib is a pill. You take ribociclib once a day for 21 days, then take 7 days off. You continue this schedule for 3 years. Ribociclib is only given in combination with an aromatase inhibitor.
Learn more about the hormone therapy drugs tamoxifen and aromatase inhibitors.
When do you begin taking abemaciclib or ribociclib?
You begin taking abemaciclib or ribociclib after breast cancer surgery.
If you’re also getting chemotherapy, you begin taking abemaciclib or ribociclib after you’ve completed chemotherapy (and after radiation therapy, if you’re getting radiation therapy).
Side effects of abemaciclib and ribociclib
Before you begin taking abemaciclib or ribociclib, talk with your health care provider about possible side effects and how to manage them.
Grapefruit and grapefruit juice should be avoided while taking abemaciclib or ribociclib, as they may increase blood levels of these drugs [139,332].
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, abemaciclib can cause liver problems. Your liver function will be checked before treatment begins and throughout your treatment. This is to help make sure there are no problems, or if there are problems, they’re caught early. In rare cases, abemaciclib 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 abemaciclib. |
Ribociclib |
Possible side effects include low white blood cell counts, nausea, fatigue, diarrhea, hair loss, vomiting, constipation, headache and back pain. In some cases, ribociclib can cause liver problems. Your liver function will be checked before treatment begins and throughout your treatment. This is to help make sure there are no problems, or if there are problems, they’re caught early. In rare cases, ribociclib 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, ribociclib 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 ribociclib. |
Adapted from select sources [139,332]. | |
CDK4/6 inhibitors and metastatic breast cancer treatment
The CDK4/6 inhibitors abemaciclib, ribociclib and palbociclib are FDA-approved for the treatment of some metastatic breast cancers.
Learn about CDK4/6 inhibitors and metastatic breast cancer treatment.
Under study
Palbociclib (Ibrance)
Palbociclib is FDA-approved for the treatment of metastatic breast cancer. However, among people with early breast cancer, it does not appear to lower the risk of breast cancer recurrence [315-316].
Neoadjuvant therapy
Abemaciclib and ribociclib are FDA-approved for the adjuvant treatment (given after surgery) of some early breast cancers. They are under study for use in the neoadjuvant treatment (given before surgery) setting [141,331].
Learn more about emerging drug therapies for early breast cancer.
Treatment guidelines
Although the exact treatment for breast cancer varies from person to person, evidence-based guidelines help make sure high-quality care is given. These guidelines are based on the latest research and agreement among experts.
The National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) are respected organizations that regularly review and update their guidelines.
In addition, the National Cancer Institute (NCI) has treatment overviews.
Talk with your health care team about which treatment guidelines they follow.
After you get a recommended treatment plan from your health care team, study your treatment options. Together with your health care team, make thoughtful, informed decisions that are best for you. Each treatment has risks and benefits to consider along with your own values and lifestyle.
Prescription drug assistance
Prescription drug costs 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.
Abemaciclib and ribociclib are pills, so they’re covered under your health insurance plan’s prescription drug benefit rather than the plan’s medical benefit. This means there are usually out-of-pocket costs, which can add up over time.
You may qualify for programs that help with drug costs or offer low-cost or free prescriptions.
Many cancer centers have financial counselors who can discuss insurance and cost coverage with you.
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. 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. Se habla español. |
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Susan G. Komen®‘s position on fairness in oral cancer drug coverage |
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Insurance coverage of oral cancer drugs Cancer medications given through an IV into a vein or by an injection (under the skin or into a muscle) are usually covered under a health insurance plan’s medical benefit. However, oral cancer drugs (cancer medications that are pills) 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 for 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. |
Clinical trials
Research is ongoing to improve all areas of treatment for breast cancer.
New therapies are being studied in clinical trials. The results of these studies will decide whether these therapies become part of the standard of care.
After discussing the benefits and risks with your health care provider, we encourage you to consider joining a clinical trial.
Susan G. Komen® Patient Care Center |
If you or a loved one needs information or resources about clinical trials, the Patient Care Center can help. Contact the Komen Breast Care Helpline at 1-877-465-6636 or email clinicaltrialinfo@komen.org. Se habla español. |
BreastCancerTrials.org in collaboration with Komen offers a custom matching service to help find clinical trials that fit your needs.
Learn more about clinical trials.
Susan G. Komen® Support Resources |
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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 10/02/24
