You’ll want to keep up with the latest findings on advanced breast cancer. Scientists are working toward new drugs, a better understanding of the disease itself, and what helps while you go through treatment.

New Medicines

The FDA recently expanded its approval for palbociclib (Ibrance), a drug that targets a protein called CDK 4/6. Doctors can now use it in combination with fulvestrant, a hormonal-therapy drug that targets estrogen. It may be an option if you have metastatic breast cancer that is “hormone-receptor positive,” and you don’t have a type of breast cancer called “HER2,” which promotes the growth of cancer cells. 

The FDA based its decision, in part, on the results of a clinical trial that found that palbociclib plus fulvestrant slowed down metastatic breast cancer by about 5 months.

The agency has also pledged to speed up its review of an immunotherapy drug called sacituzumab govitecan (IMMU-132) for certain people with metastatic breast cancer who have already tried at least two treatments.. It targets a protein called Trop-2 that’s found in many types of cancer.

More New Drugs in the Works

These medications aren’t available yet, but researchers are studying them.

PARP inhibitors. These drugs target PARP -- an enzyme involved in DNA repair -- and may help people with a BRCA1 or BRCA2 gene mutation.

Tyrosine kinase inhibitors. These drugs block certain enzymes. One of the meds, called lapatinib (Tykerb), is already FDA-approved to treat HER2-positive metastatic breast cancer. Another, called neratinib, may also do that, a new study shows. The results show that neratinib improved survival when given after chemotherapy.

More targeted HER-2 therapies. About 1 in 5 people with breast cancer have too much of a growth-promoting protein known as HER2. Drugs that target this protein are becoming more sophisticated. Examples include margetuximab, a drug that shows promise in reducing tumors, and ONT-380, which may cause fewer side effects.

Other immunotherapy drugs. These meds work by boosting your immune system or by providing a man-made version of an immune system protein. Apart from IMMU-132, another immunotherapy drug, pembrolizumab, shows promise in clinical trials as a potential treatment for metastatic triple-negative breast cancer.

Learning More About How the Cancer Spreads

A new study challenges the long-held belief that the disease spreads when a single cell “escapes” from the tumor and travels through the bloodstream to other organs.

Researchers at Fred Hutchinson Cancer Research Center and Johns Hopkins Medical Institute discovered that breast cancer cells actually travel in clusters throughout all stages of this spreading, or "metastasis." Having a better understanding of how cancer behaves will help researchers come up with more targeted ways to stop it.

A few months earlier, a study published in Nature also turned the tables on our understanding of how breast cancer cells move through the body. Experts had thought that these cells have to go through a shape-changing process called EMT before they can spread. But the new study shows that breast tumor cells that went through EMT weren’t involved in metastasis.

“There is a substantial effort underway to develop drugs aimed at reversing the EMT process in order to halt metastasis, but our findings suggest that this approach may not work,” researcher Vivek Mittal, PhD, said in a statement.

How You Can Help

Ask your doctor if there are clinical trials that would be a good fit for you. They test new treatments before they’re available to the public. Your doctor, and the study leaders, can let you know what’s being tested, what your commitment involves, and what the risks and benefits are.

You may also want to look into the Metastatic Breast Cancer Project (mbcproject.org), led by the Broad Institute and the Dana-Farber Cancer Institute. It describes itself as “a nationwide movement of patients, doctors, and scientists” with the common goal of “speed[ing] the development of future therapies.”

To get involved, fill out an online consent form allowing the project to contact your doctors for your medical records and a portion of your stored tumor samples. This information will be added to a national database and shared with metastatic breast cancer researchers everywhere.

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Important Safety Information

Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR can cause serious side effects, such as lung or breathing problems, infections, or kidney failure. Some of these side effects can be severe and can even lead to death. Your health care team may have ways to help manage side effects that do occur. It's important to talk with your doctor or nurse about side effects you experience and the best ways to manage them. Serious side effects include:

Lung or Breathing Problems: Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5°F or above, have chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.

Kidney Failure: Patients taking AFINITOR may develop kidney failure. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.

Delayed Wound Healing: AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR, tell your health care provider about all your medical conditions, including if you:

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of vaccine, ask your health care provider
  • Have other medical conditions
  • Are pregnant or could become pregnant. AFINITOR can cause harm to your unborn baby. If you are able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John's wort (Hypericum perforatum), medicines that weaken your immune system (your body's ability to fight infections and other problems), or medicines for:

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects

The most common side effect of AFINITOR in treating advanced hormone receptor-positive, HER2-negative breast cancer was mouth ulcers and sores (67%). Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or mouth gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects of AFINITOR include:

  • Infections (50%)
  • Rash (39%)
  • Feeling tired (36%)
  • Diarrhea (33%)
  • Loss of appetite (30%)
  • Nausea (29%), vomiting (17%)
  • Weight loss (25%)
  • Cough (24%), shortness of breath (21%)
  • Abnormal taste (22%)
  • Headache (21%)
  • Pain in arms and legs (9%), back (14%), joints (20%)
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body (19%)
  • Nose bleeds (17%)
  • Fever (15%)
  • Constipation (14%)
  • High blood glucose (14%)
  • Difficulty sleeping (13%)
  • Feeling weak (13%)
  • Itching (13%)
  • Dry mouth (11%)
  • Hair loss (10%)

Other side effects that may occur with AFINITOR:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR. For more information, ask your health care provider or pharmacist. 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 for AFINITOR, including Patient Information.

The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.

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Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2017 Novartis 8/17 AFB-1169098

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