What is Ki-67 and how does it relate to breast cancer?

Ki-67 (pronounced “key sixty-seven”) is a type of protein found in cells that are growing and dividing. For people with breast cancer, Ki-67 is used as a biomarker, or indicator, to help determine how quickly the tumor is growing.

How does my doctor test for Ki-67?

To test for Ki-67,* your doctor may send a sample of previously biopsied breast cancer tissue to a lab for analysis. You'll receive the results in your pathology report, which will show what percentage of cancer cells express Ki-67. In the monarchE study, Ki-67 levels ≥20% indicated 'high' Ki-67. If levels of Ki-67 are high, that means cancer cells are quickly dividing and creating new cells.

What happens if my Ki-67 levels are high?

Because not all early breast cancer is the same, your doctor may use Ki-67 along with other information to help determine the likelihood of your cancer returning, and which treatments may work best to reduce the risk of recurrence.

Early breast cancer

Being diagnosed with early breast cancer (EBC) can be difficult but learning about the disease and how to talk to your doctor can help.

What is early breast cancer?

Early breast cancer is when cancer is found only in the breast or nearby lymph nodes, and has not spread to other parts of the body.

approximately 70% of women with breast cancer have HR+ HER2-

There are different subtypes of breast cancer, based on whether hormone receptors, such as estrogen receptors, or other proteins are involved in how the cancer divides and grows. The most common type is HR+, HER2– breast cancer, which makes up approximately 70% of all breast cancers.

Understanding your early breast cancer diagnosis and prognosis

After being diagnosed with early breast cancer, your doctor may talk to you about a variety of risk factors. These risk factors may impact the prognosis, or course of the disease, and the likelihood of your breast cancer returning. They also inform which treatments may be most helpful. Risk factors can include:

Tumor size
Lymph node involvement, or whether the cancer has spread from the breast to the nearby lymph nodes
Tumor grade, refers to the degree to which the cells in the breast tumor look like normal cells vs cancer cells

Along with hormone receptor status and HER2 status, these disease factors help to determine the best path forward for treatment. They are also used to help understand the risk of the breast cancer recurring, or coming back again, after or during treatment.

What does it mean if my breast cancer has spread to the lymph nodes?

Lymph nodes are structures that contain immune cells and are part of what is called the lymphatic system. Lymph node involvement, or lymph node-positive breast cancer, means the cancer has spread to the lymph nodes in nearby areas, like the underarm.

Nodal involvement is the first indication that the cancer is moving beyond the original tumor in the breast. Early breast cancer that is node-positive is considered to have a higher risk of recurrence.

Facts about breast cancer

Breast cancer is the most common cancer among women worldwide. About 1 in 8 U.S. women will develop breast cancer over the course of her lifetime

Men and women of all ages can be diagnosed with breast cancer

1 in 3 women with early breast cancer may experience a cancer recurrence

Lymph node involvement, tumor size, and many other factors can impact the risk of recurrence in HR+, HER2– breast cancer

Breast cancer with nodal involvement, or node-positive, is considered high risk, meaning the chance of recurrence can be even greater

Approximately 70% of all breast cancers are the subtype HR+, HER2–

Early breast cancer treatment options

Treatment involves removing the breast tumor from your body and providing therapy to prevent the cancer from coming back. Treatment for early breast cancer usually involves a combination of surgery, radiation therapy, and systemic therapies, such as chemotherapy and hormone therapy.

Early breast cancer treatment

Surgery

Surgery is often the first form of treatment for early breast cancer. It can include a mastectomy—a procedure to remove the entire breast—or a lumpectomy to remove only the tumor. The type of treatment given after surgery depends on the characteristics related to the tumor and disease, such as:

Tumor size
Extent of nodal involvement (ie, number of lymph nodes involved)
Tumor characteristics (Hormone receptor status, HER2 status)

Treatment that is given following surgery is called adjuvant therapy. Many patients who receive Verzenio in the early breast cancer setting will have received therapy before surgery (neoadjuvant therapy), such as chemotherapy, because their cancer has certain high risk characteristics.

Chemotherapy and radiation

Chemotherapy can be given either before surgery (neoadjuvant) or after surgery (adjuvant). Chemotherapy can help lower the risk of the cancer returning, by killing residual or leftover cancer cells that may be circulating in the body. Chemotherapy is considered a systemic therapy because it travels throughout the body and affects cells beyond the breast.

Radiation is generally given after surgery and chemotherapy, and uses targeted beams of intense energy, such as high-energy x-rays, to kill cancer left in or around the breast or nearby lymph nodes.

Hormone therapy and other targeted therapies

In HR+, HER2– breast cancer, the hormone estrogen can act like fuel to any remaining cancer cells, helping them to divide and grow. Following surgery, people with HR+, HER2–, early breast cancer may continue treatment with hormone therapy, which targets and blocks hormones like estrogen to help prevent cancer cells from growing and spreading. Hormone therapy may also be referred to as endocrine therapy.

Like chemotherapy, the goal of adjuvant hormone therapy is also to help prevent or lower the risk of recurrence.

Partnering with your doctor

Asking the right questions will help you and your doctor determine the best treatments to reduce your risk of recurrence.

Here are some questions to think about asking your doctor:

Can you recommend additional resources that would help educate me about my disease and treatment?
Does my early breast cancer have a high risk of recurrence (meaning a higher likelihood of coming back)? If so, what risk factors do I have?
What are my options for treating my HR+, HER2– breast cancer with nodal involvement?
What treatment options are available to reduce risk of recurrence after surgery, chemotherapy, and/or radiation?
Is Verzenio right for me in combination with my hormone therapy?
How is Verzenio taken?
If Verzenio is right for me, what can I expect during treatment?
What are the potential side effects with Verzenio?
How will this treatment affect my quality of life?
Do you know of any resources to help with financial support for Verzenio?

Learn more about how Verzenio + hormone therapy can be used to treat HR+, HER2–, node-positive, early breast cancer

SAFETY SUMMARY

Warnings - Verzenio may cause serious side effects, including:

Diarrhea is common with Verzenio, may sometimes be severe and may cause dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. If you develop diarrhea during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, stop your treatment, or decrease your dose.

If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away.

Low white blood cell counts (neutropenia) are common with Verzenio and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or wait before starting your next month of treatment. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.

Verzenio may cause severe or life-threatening inflammation (swelling) of the lungs during treatment that can lead to death. If you develop lung problems during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

Trouble breathing or shortness of breath
Cough with or without mucus
Chest pain

Verzenio can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment. If you develop liver problems during treatment with Verzenio, your health care provider may reduce your dose or stop your treatment. Tell your healthcare provider right away if you have any of the following signs or symptoms of liver problems:

Feeling very tired
Pain on the upper right side of your stomach area (abdomen)

Loss of appetite
Bleeding or bruising more easily than normal

Verzenio may cause blood clots in your veins, or in the arteries of your lungs. Verzenio may cause serious blood clots that have led to death. If you develop blood clots during treatment with Verzenio, your healthcare provider may tell you to temporarily stop taking it. Tell your healthcare provider right away if you have any of the following signs and symptoms of a blood clot:

Pain or swelling in your arms or legs
Shortness of breath
Chest pain

Fast breathing
Fast heart rate

Verzenio can harm your unborn baby. Use effective birth control (contraception) during treatment and for 3 weeks after the last dose of Verzenio and do not breastfeed during treatment with Verzenio and for at least 3 weeks after your last dose. Verzenio may affect the ability of males to father a child.

Common side effects

The most common side effects of Verzenio include:

Nausea
Infections
Low red blood cell counts (anemia)
Decreased appetite
Headache
Hair thinning or hair loss (alopecia)

Abdominal pain
Tiredness
Low white blood cell counts (leukopenia)
Vomiting
Low platelet counts (thrombocytopenia)

These are not all the possible side effects of Verzenio.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before you use Verzenio, tell your healthcare provider about all your medical conditions, including:

If you have fever, chills, or other signs of infection.
If you have a history of blood clots in your veins.
Have lung or breathing problems.
Have liver or kidney problems.
If you are pregnant, plan to become pregnant, or are breastfeeding.
About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

How to take

Take Verzenio exactly as your healthcare provider tells you.
Your healthcare provider may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your healthcare provider.
Verzenio may be taken with or without food.
Swallow Verzenio tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take Verzenio tablets if they are broken, cracked, or damaged.
Take your doses of Verzenio at about the same time every day.
If you vomit or miss a dose of Verzenio, take your next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.

What to avoid during treatment

Avoid taking ketoconazole during treatment with Verzenio. Tell your healthcare provider if you take a medicine that contains ketoconazole
Avoid grapefruit and products that contain grapefruit during treatment with Verzenio. Grapefruit may increase the amount of Verzenio in your blood

Learn more

Verzenio is a prescription medicine. For more information, call 1-800-545-5979.

This summary provides basic information about Verzenio but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Verzenio and how to take it. Your healthcare provider is the best person to help you decide if Verzenio is right for you.

AL CON BS 03MAR2023

Verzenio^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

INDICATIONS

Verzenio^® (ver-ZEN-ee-oh) is used to treat certain types of breast cancer known as HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2 negative) breast cancer.

It is a medicine you can take if:

You have node-positive early breast cancer that has a high risk of coming back as determined by your healthcare provider. Verzenio is given along with hormonal therapy to women and men.
Or, the cancer has spread to other parts of the body (metastasized). If you are female or male, then Verzenio is given with an aromatase inhibitor as initial endocrine-based therapy. If you are a female or male, and the cancer has gotten worse after hormonal therapy, then Verzenio is given with fulvestrant. If you are female or male and the cancer has gotten worse after both hormonal therapy and chemotherapy, then Verzenio is given by itself.

It is not known if Verzenio is safe and effective in children.