A Scientific Advancement In The Treatment Of HR+, HER2- Metastatic Breast Cancer
A First-Of-Its-Kind Treatment
Which Type Of Breast Cancer Is IBRANCE For?
IBRANCE is for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC)—breast cancer that has spread to other parts of the body—or HR+/HER2- mBC.
Hormone receptor positive includes both estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) subtypes. If your subtype is ER+ and/or PR+, you're more likely to respond to hormone therapies, like an aromatase inhibitor or fulvestrant, that reduce the effects of hormones.
If your subtype is HER2-, your cancer cells have less HER2 protein expression and, therefore, are less likely to respond to anti-HER2 therapies.
HR+, HER2- is the most common subtype of metastatic breast cancer, representing approximately 60% of all cases.
IBRANCE combination therapy was studied in 2 different clinical trials. Whether you’ve previously received hormonal therapy for your metastatic disease before or not, talk to your healthcare team to learn if IBRANCE is right for you.
Trials Results
- IBRANCE + Aromatase Inhibitor
- IBRANCE + Fulvestrant
In combination with any aromatase inhibitor, IBRANCE is for adult patients as their first hormonal based therapy.
IBRANCE was studied in a clinical trial of 666 postmenopausal women with ER+/HER2- metastatic breast cancer who had not received prior hormone therapy for their metastatic disease. Patients were split into 2 groups. The first group took IBRANCE and letrozole (an aromatase inhibitor) together, while the second group took letrozole and placebo.
Together, the combination of IBRANCE and letrozole delayed disease progression for a median time of 24.8 months versus 14.5 months for those that received letrozole and placebo. Patients taking IBRANCE with letrozole reduced their risk of disease progression by 42% compared to those taking letrozole and placebo.
This means that IBRANCE plus letrozole was significantly more effective at delaying disease progression versus letrozole and placebo.
This clinical trial measured the total time patients lived from the start of treatment (overall survival). No significant difference in overall survival was observed between patients who had taken IBRANCE plus letrozole and those who had taken letrozole plus placebo.
In combination with fulvestrant, IBRANCE is for adult patients who have previously received hormonal therapy for their disease.
IBRANCE was studied in a clinical trial of 521 women with HR+/HER2- metastatic breast cancer, regardless of their menopausal state, who had received hormone therapy either for early stage breast cancer or for metastatic disease. Patients were split into 2 groups. The first group took IBRANCE and fulvestrant together, while the second group took fulvestrant and placebo.
Together, the combination of IBRANCE and fulvestrant delayed disease progression for a median time of 9.5 months versus 4.6 months for those that received fulvestrant and placebo. Patients taking IBRANCE with fulvestrant reduced their risk of disease progression by 54% compared to those taking fulvestrant and placebo.
This means that IBRANCE plus fulvestrant was 2x more effective at delaying disease progression versus fulvestrant and placebo.
This clinical trial measured the total time patients lived from the start of treatment (overall survival). No significant difference in overall survival was observed between patients who had taken IBRANCE plus fulvestrant and those who had taken fulvestrant plus placebo.
How IBRANCE Works
SLOWING THE PROGRESSION OF METASTATIC BREAST CANCER
IBRANCE is a targeted therapy known as a CDK 4/6 inhibitor. It is not a traditional chemotherapy. IBRANCE works to put the brakes on cell growth in both healthy and cancer cells. This helps slow the progression of cancer, but it can also cause side effects, some of which are serious. Please see the Important Safety Information to learn more.
Learn How IBRANCE & Hormonal Therapies Work Together
The video below shows how IBRANCE and hormonal therapies bring the power of two therapies together to help delay the progression of a certain type of metastatic breast cancer.
https://players.brightcove.net/1852113022001/JpBcT6sXX_default/index.html?videoId=6329473810112
Starting a new treatment can be overwhelming. You—and those who care for you—may have questions, and that’s to be expected. This video can help explain how IBRANCE® (palbociclib) works as a treatment for a certain type of metastatic breast cancer.
Metastatic breast cancer, or mBC, is breast cancer that has spread to other parts of the body, such as the bones, liver, lungs, and brain.
Let’s now take a closer look at the role hormones play in the body as well as how both IBRANCE and hormonal therapy work.
Hormones are substances that act as chemical messengers, traveling through the bloodstream to help perform activities specific to cells and organs.
Estrogen and progesterone are two such hormones that occur naturally in the body. These hormones attach to hormone receptors in order to help promote normal cell growth and function.
Hormone receptors are proteins found within and on the surface of cells, including breast cells. The binding of hormones to the receptors is like flipping an on switch for the activity and function of the cell.
The binding of hormones like estrogen and/or progesterone to their hormone receptors in cells triggers cell growth by communicating with proteins known as CDK4 and CDK6. These proteins play an important role in cell division.
The breast cancer we are focused on here is known as hormone receptor positive or (HR+), human epidermal growth factor receptor 2-negative or (HER2-) metastatic breast cancer. Or, more simply put, HR+, HER2- mBC.
In HR+, HER2- mBC, the increase of certain proteins, like CDK4 and CDK6, can contribute to the cell being overactive. That overactivity can cause the cell to lose its ability to regulate its growth and division.
This can lead to the production of many cancerous cells that can move to different areas of the body. Blocking the ways in which a cell grows and divides can slow the progression of certain breast cancers, including HR+, HER2- mBC.
This is where IBRANCE can play a role.
IBRANCE is taken in combination with hormonal therapy to help delay the progression of metastatic breast cancer.
IBRANCE works inside the cell to disrupt the activity of the proteins CDK4 and CDK6, which can keep both healthy and cancer cells from dividing.
Hormonal therapy works to block or reduce the binding of hormones with hormone receptors to prevent the cells from growing and dividing.
By working together, IBRANCE and hormonal therapy can help delay the progression of HR+, HER2- metastatic breast cancer.
Talk to your doctor if you have any additional questions about IBRANCE. Information can also be found throughout IBRANCE.com.
Side Effects
While on therapy, be sure to share any side effects you experience with your healthcare team right away.
SERIOUS SIDE EFFECTS
- Low white blood cell counts (neutropenia) are very common when taking IBRANCE (palbociclib) and may cause serious infections that can lead to death. Your healthcare team should check your white blood cell counts before and during treatment.
- If you develop low white blood cell counts during treatment with IBRANCE, your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your doctor right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.
- Lung problems (pneumonitis). IBRANCE may cause severe inflammation of the lungs during treatment that can lead to death. Tell your doctor right away if you have any new or worsening symptoms, including:
- chest pain
- cough with or without mucus
- trouble breathing or shortness of breath
Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe.
THE MOST COMMON SIDE EFFECTS
- In addition to low white blood cell counts (neutropenia), low red blood cell counts and low platelet counts are common with IBRANCE. Call your healthcare team right away if you feel dizzy or weak, notice that you bleed or bruise more easily, or experience shortness of breath or nosebleeds while on treatment.
- Other most common side effects include infections, tiredness, nausea, sore mouth, abnormalities in liver blood tests, diarrhea, hair thinning or hair loss, vomiting, rash, and loss of appetite.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of IBRANCE. Call your doctor for medical advice about side effects.
Brochures To Download
Patient Guide
Download our Patient Guide for an overview of IBRANCE.
Caregiver Guide
Download our Caregiver Guide for information specific for caregivers.
IBRANCE FAQs
IBRANCE 125 mg capsules and tablets are a prescription medicine used in adults to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other parts of the body (metastatic) in combination with:
- an aromatase inhibitor as the first hormonal based therapy, or
- fulvestrant in people with disease progression following hormonal therapy.
Talk to your healthcare team to see if IBRANCE is right for you.
IBRANCE may cause serious side effects, including:
Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking IBRANCE and may cause serious infections that can lead to death. Your doctor should check your white blood cell counts before and during treatment.
If you develop low white blood cell counts during treatment with IBRANCE, your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your doctor right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.
Lung problems (pneumonitis). IBRANCE may cause severe inflammation of the lungs during treatment that can lead to death. Tell your doctor right away if you have any new or worsening symptoms, including:
- chest pain
- cough with or without mucus
- trouble breathing or shortness of breath
Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe.
For more information, see side effects.
Before taking IBRANCE, tell your doctor about all of your medical conditions, including if you:
- have fever, chills, or any other signs or symptoms of infection.
- have liver or kidney problems.
- are pregnant or plan to become pregnant; IBRANCE can harm your unborn baby.
- Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of IBRANCE. Your doctor may ask you to take a pregnancy test before you start treatment with IBRANCE.
- Males with female partners who can become pregnant should use effective birth control during treatment with IBRANCE for at least 3 months after the last dose of IBRANCE.
- are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into your breast milk. Do not breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.
Yes. To monitor your side effects, your healthcare team will give you a blood test to check your complete blood cell count before you start taking IBRANCE and at the beginning of every cycle.
Additionally, for the first 2 treatment cycles, you'll need a complete blood cell count done on day 15 as well. Make sure to tell your healthcare team which day you start your first and second cycles, so they can schedule your day 15 appointment at the right time.
A complete blood cell count is the only monitoring requirement for IBRANCE. Patients taking IBRANCE do not require EKG heart monitoring. Your healthcare team will determine if any additional monitoring is needed.
If your blood test results indicate low white blood cell counts (neutropenia), your healthcare team may temporarily hold or adjust your dose. It's not uncommon to have doses modified throughout treatment. Be sure to follow your dosing schedule exactly as your healthcare team prescribes and talk to your doctor if you have any questions about monitoring.
Yes, the Pfizer Oncology Together Co-Pay Savings Program may help eligible, commercially insured patients save on out-of-pocket costs, and Pfizer Oncology Together can connect patients who are uninsured, underinsured, or have government insurance with resources that may help you pay for your IBRANCE prescription.
For eligible, commercially insured patients, sign up now for co-pay assistance. Limits, terms, and conditions apply.
Whether it’s financial assistance or personalized support, Pfizer Oncology Together will help you find the resources you need—all in one place. Just give us a call at 1-844-9-IBRANCE.
