There are many factors that can help you find a metastatic breast cancer treatment. It is important to know your stage of disease, along with the specific type and mutation, as this information will help you better understand what may cause your cancer to grow. HR+, HER2- is the most common type of breast cancer. In this type, hormones help the cancer to grow.
mBC can occur 5, 10, or even 15 years after an early-stage diagnosis.
mBC can grow with the help of proteins, hormones, and sometimes mutations (or abnormalities) in certain genes, such as PIK3CA mutations.
Sometimes mutations (or abnormalities) in genes can contribute to the spread of cancer. In HR+, HER2- breast cancer, the most common mutation is a PIK3CA mutation, which has been linked to cancer growth. Just as your HR and HER2 status inform your doctor whether certain proteins fuel your cancer, your PIK3CA mutation status tells your doctor whether a common gene mutation may be contributing to the growth of your cancer.
If you have the PIK3CA mutation and progressed on or after an endocrine therapy, PIQRAY may be right for your HR+, HER2- metastatic breast cancer treatment. Getting tested for the PIK3CA mutation is the first step. Ask your doctor about testing.
About 155,000 people in the United States are currently living with metastatic breast cancer.
About 70% of all people with breast cancer are HR+, HER2-.
About 40% of all people with HR+, HER2- mBC have a PIK3CA mutation.
The stages of breast cancer range from 0-4. When breast cancer has progressed to stage 3 or 4, it’s considered advanced breast cancer. Explore the toggle to see the differences in stage 3 and 4.
Stage 3 breast cancer is when the cancer has spread beyond the breast and into nearby lymph nodes and muscles, but it has not yet spread to distant sites throughout the body.
Stage 4 breast cancer (also referred to as metastatic breast cancer, or mBC) is when cancer that began in the breast spreads to other parts of the body. Even when breast cancer is found elsewhere in the body, it’s still breast cancer, and should not be considered as any other type of cancer. Breast cancer can spread to any part of the body, but it most commonly metastasizes in the bones, lungs, liver, or brain.
Important Safety Information
Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.
PIQRAY may cause serious side effects, including:
Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with PIQRAY...
Do not take PIQRAY if you have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.
PIQRAY may cause serious side effects, including:
Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with PIQRAY
Severe skin reactions: Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever
High blood sugar levels (hyperglycemia): Hyperglycemia is common with PIQRAY and may be severe. Your health care provider will monitor your blood sugar levels before you start and during treatment with PIQRAY. Your health care provider may monitor your blood sugar levels more often if you have a history of type 2 diabetes. Tell your health care provider right away if you develop symptoms of hyperglycemia, including excessive thirst, dry mouth, urinating more often than usual or having a higher amount of urine than normal, increased appetite with weight loss, confusion, nausea, vomiting, fruity odor on breath, difficulty breathing, or dry or flushed skin
Lung problems (pneumonitis): Tell your health care provider right away if you develop new or worsening symptoms of lung problems, including shortness of breath or trouble breathing, cough, or chest pain
Diarrhea or colitis (inflammation of your intestines): Diarrhea is common with PIQRAY and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your health care provider right away, if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with PIQRAY. Your health care provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis
Your health care provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with PIQRAY if you get certain serious side effects.
Before you take PIQRAY, tell your health care provider about all of your medical conditions, including if you:
have a history of diabetes
have a history of skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling
are pregnant or plan to become pregnant. PIQRAY can harm your unborn baby
Females who are able to become pregnant:
Your health care provider will check to see if you are pregnant before you start treatment with PIQRAY
You should use effective birth control during treatment with PIQRAY and for 1 week after the last dose. Talk to your health care provider about birth control methods that may be right for you during this time
If you become pregnant or think you are pregnant, tell your health care provider right away
Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with PIQRAY and for 1 week after the last dose. If your female partner becomes pregnant, tell your health care provider right away.
are breastfeeding or plan to breastfeed. It is not known if PIQRAY passes into your breast milk. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose
You should also read the full Prescribing Information of fulvestrant for important pregnancy, contraception, infertility, and lactation information.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIQRAY and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.
The most common side effects of PIQRAY when used with fulvestrant include:
rash
nausea
tiredness and weakness
decreased appetite
mouth sores
vomiting
weight loss
hair loss
changes in certain blood tests
PIQRAY may affect fertility in males and in females who are able to become pregnant. Talk to your health care provider if this is a concern for you.
These are not all the possible side effects of PIQRAY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information. ↗
6/23 274262
Approved Use
PIQRAY® (alpelisib) tablets is a prescription medicine used in combination with the medicine fulvestrant to treat women who have gone through menopause, and men:
who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and...
PIQRAY® (alpelisib) tablets is a prescription medicine used in combination with the medicine fulvestrant to treat women who have gone through menopause, and men:
who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and
whose disease has progressed on or after endocrine therapy
Your health care provider will test your cancer for an abnormal "PIK3CA" gene to make sure that PIQRAY is right for you.
It is not known if PIQRAY is safe and effective in children.