PI3 Kinase and AKT Inhibitors for Metastatic Breast Cancer

What are PI3 kinase and AKT inhibitors?

The PI3 kinase, AKT and PTEN enzymes are on the same cellular pathway. They are important in cell growth and division.

Some breast cancers have a PIK3CA, AKT1 or PTEN gene mutation. These are mutations in the genes of the breast cancer cells, not the genes of the person.

A PIK3CA, AKT1 or PTEN tumor gene mutation can affect PI3 kinase and/or AKT activity and cause the cancer to grow. PI3 kinase and AKT inhibitors are designed to block this action.

Testing for PIK3CA, AKT1 and PTEN tumor gene mutations

All hormone receptor-positive, HER2-negative metastatic breast cancers should be tested for PIK3CA, AKT1 and PTEN tumor gene mutations [121,124]. These mutations are in the genes of the tumor cells, not in the normal (non-cancer) cells in a person’s body.

Testing for tumor gene mutations can be done by testing the tumor DNA in your blood or by testing tumor tissue [121].

  • Some metastatic breast cancers that have a PIK3CA tumor gene mutation can be treated with the PI3 kinase inhibitor alpelisib (Piqray).
  • Some metastatic breast cancers that have a PIK3CA, AKT1 or PTEN tumor gene mutation can be treated with the AKT inhibitor capivasertib (Truqap).

PI3 kinase and AKT inhibitors for metastatic breast cancer treatment

Drug category

Drug name

Brand name

How is it given?

PI3 kinase inhibitor

Alpelisib

Piqray

Pill

AKT inhibitor

Capivasertib

Truqap

Pill

Alpelisib and capivasertib, each in combination with hormone therapy, are used to treat some hormone receptor-positive, HER2-negative metastatic breast cancers.

Alpelisib (Piqray) and metastatic breast cancer treatment

Alpelisib in combination with the hormone therapy drug fulvestrant is FDA-approved to treat hormone receptor-positive, HER2-negative metastatic breast cancers that:

  • Have a PIK3CA tumor gene mutation
  • Have been treated with at least one hormone therapy in the past

The combination of alpelisib and fulvestrant can give more time before the cancer worsens compared to fulvestrant alone [20].

 52829-3.gif

For a summary of research studies on PI3 kinase inhibitors and metastatic breast cancer treatment, visit the Breast Cancer Research Studies section.

Learn more about treatment for metastatic breast cancer.

Learn about emerging areas in treatment for metastatic breast cancer.

Capivasertib (Truqap) and metastatic breast cancer treatment

Capivasertib in combination with the hormone therapy drug fulvestrant is FDA-approved to treat some hormone receptor-positive, HER2-negative metastatic breast cancers that:

  • Have a PIK3CA, AKT1 or PTEN tumor gene mutation
  • Have been treated with at least one hormone therapy in the metastatic setting in the past

The combination of capivasertib and fulvestrant can give people more time before the cancer worsens compared to fulvestrant alone [122].

 52829-3.gif

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

Learn more about treatment for metastatic breast cancer.

Learn about emerging areas in treatment for metastatic breast cancer.

How are alpelisib and capivasertib given?

Alpelisib and capivasertib are pills.

Side effects of alpelisib and capivasertib

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.

Capivasertib

Possible side effects include diarrhea, rash and other skin problems, increased blood sugar levels, decreased white blood cell counts, nausea, vomiting and fatigue.

Adapted from select sources [20-21,122,125].

Before you begin taking alpelisib or capivasertib, 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 the treatment is 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® 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.

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.

Learn what Komen is doing to help people find and participate in breast cancer clinical trials, including trials supported by Komen.

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.

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® METASTATIC BREAST CANCER SUPPORT RESOURCES

  • Do you need help with a metastatic breast cancer diagnosis? We’re here for you. The Komen Patient Care Center is your trusted, go-to source for timely, accurate breast health and breast cancer information, services and resources. Our navigators offer free, personalized support to patients, caregivers and family members, including education, emotional support, financial assistance, help accessing care and more. Get connected to a Komen navigator by contacting the Breast Care Helpline at 1-877-465-6636 or email helpline@komen.org to get started. All calls are answered Monday through Thursday, 9 a.m to 7 p.m. ET and Friday, 9 a.m. to 6 p.m. ET. Se habla español.
  • We offer an online support community through our closed Komen Metastatic Breast Cancer (Stage IV) 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. Click the link above or visit Facebook and search for Komen Metastatic Breast Cancer (Stage IV) Group and request to join.
  • 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 metastatic breast cancer 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 Real Pink podcast series covers many relevant topics for people living with metastatic breast cancer and caregivers.
  • Our fact sheets, booklets and other education materials offer additional information.

Updated 01/10/24

TOOLS & RESOURCES

Questions to Ask Your Doctor

Research Fast Facts