PI3 Kinase Inhibitors for Metastatic Breast Cancer
What are PI3 kinase inhibitors?
PI3 kinase is an enzyme important in cell growth. The PIK3CA gene helps control PI3 kinase enzyme activity.
Some breast cancers have a PIK3CA gene mutation. This mutation is in the genes of the breast cancer cells, not the genes of the person. To find out if the cancer cells have a PIK3CA mutation, you may have a blood test that checks for tumor DNA in your blood, or the tumor tissue will be tested.
PI3 kinase inhibitors are drugs designed to interrupt PI3 kinase signals and stop the growth of breast cancer cells with PIK3CA gene mutations.
Alpelisib (Piqray) is a PI3 kinase inhibitor. Alpelisib is used in combination with hormone therapy to treat some hormone receptor-positive metastatic breast cancers.
Testing for PIK3CA tumor gene mutations
All hormone receptor-positive, HER2-negative metastatic breast cancers should be tested for PIK3CA tumor gene mutations [121]. This can be done by testing the tumor DNA in your blood or by testing tumor tissue [4].
Some metastatic breast cancers that have a PIK3CA tumor gene mutation can be treated with the PI3 kinase inhibitor alpelisib (Piqray).
Alpelisib (Piqray) and metastatic breast cancer treatment
Alpelisib in combination with the hormone therapy fulvestrant is FDA-approved to treat hormone receptor-positive, HER2-negative metastatic breast cancers with a PIK3CA gene mutation that have been treated with hormone therapy in the past.
The combination of alpelisib and fulvestrant can give more time before the cancer worsens compared to fulvestrant alone [20].
Learn more about treatment for metastatic breast cancer.
Learn about emerging areas in treatment for metastatic breast cancer.
How is alpelisib given?
Alpelisib is a pill.
Side effects of alpelisib
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Side Effects |
Alpelisib |
Possible side effects include high blood sugar, diarrhea, nausea, decreased appetite, rash, vomiting, fatigue and hair loss. Blood sugar levels are monitored while taking alpelisib because nearly everyone who takes it gets high blood sugar levels. It’s recommended you take an antihistamine, such as cetirizine (Zyrtec), to lower the risk of rash. |
Adapted from select sources [20-21]. |
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Before you begin taking alpelisib, talk with your health care provider about possible side effects and how to manage them.
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 or discuss other options.
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.
Many clinical trials are available. Some are for the first treatment a person might get for their metastatic breast cancer, and others are for treatments later in the disease course. Consider joining a clinical trial when you’re newly diagnosed, when your oncologist is considering changing treatments 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. Se habla español. |
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.
You may also qualify for programs that help with drug costs or offer low-cost or free prescriptions.
Many cancer centers have patient 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. Funding is available for eligible individuals undergoing breast cancer treatment at any stage or living with metastatic breast cancer (stage 4). 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 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® METASTATIC BREAST CANCER SUPPORT RESOURCES |
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Updated 06/25/23
