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.
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.
High risk refers to the likelihood of one's cancer coming back, which is determined by clinical factors such as:
- 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.
Key facts about early 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–
Learn more about how Verzenio + hormone therapy can be used to treat HR+, HER2–, node-positive, early breast cancer
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.
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.
The most common side effects of taking Verzenio + hormone therapy:
- Diarrhea
- Low white blood cell counts (neutropenia, leukopenia)
- Nausea
- Infections
- Low red blood cell counts (anemia)
- Decreased appetite
- Headache
- Hair thinning or hair loss (alopecia)
- Abdominal pain
- Tiredness
- Vomiting
- Low platelet count (thrombocytopenia)
You should tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Verzenio. For more information, you should ask your doctor or pharmacist.
For HR+, HER2–, node-positive early breast cancer with a high chance of returning, as determined by your healthcare provider.
“So my doctor decided that it would be best to lower the dosage in increments. I had to decrease twice, lowering it to 50 milligrams. So we were able to actually find that sweet spot and get it lowered to the best dosage for me, and that was the one that I can maintain and still be able to be active in my kids' life.“
- Tan, a Verzenio patient
It is not known if Verzenio is safe and effective in children.
Most common side effects of Verzenio can be managed with a reduced dose. The benefit of a reduced dose of Verzenio + hormone therapy is similar to that seen in adults receiving the recommended dose.
Data from the clinical trial was further analyzed to assess the results when dose reduction was needed. These analyses were not pre-planned. Individual results may vary.
Take Verzenio exactly as your doctor tells you. Your doctor may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your doctor.
The recommended dose of Verzenio (in combination with hormone therapy) is 150 mg by mouth twice a day, taken once in the morning and once at night.
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?
If Verzenio is right for me, what can I expect during treatment?
Do you know of any resources to help with financial support for Verzenio?
How will this treatment affect my quality of life?
What are the potential side effects with Verzenio?
Hear from a real Verzenio patient
Laura's decision to move forward with Verzenio
“My first thought was I will do Verzenio if it increases the odds that my kids won't have to hear me say it's come back.” - Laura
Individual results may vary.
00:00
Caption: Verzenio logo, "Verzenio is a prescription medicine used in combination with endocrine (hormone) therapy (tamoxifen or an aromatase inhibitor) to treat adults with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2–), node-positive, early breast cancer with a high risk of coming back as determined by your healthcare provider. It is not known if it is safe and effective in children. Individual results may vary. Talk to your doctor to see if Verzenio is right for you. Participants were compensated for their time. Please see the Indication and Safety Summary at the end of this video."
00:24
[A woman and man sit on their porch. She smiles. They both look at their yard where their three children play. Short montage plays memories of their family, the children playing, the mother blowing out birthday candles.]
VO Laura: My name is Laura. I have three kids. They are fifth grade, third grade and kindergarten. This is what we're calling our golden year, where they're all in the same school building. The girls love to change outfits multiple times a day and put on different shows of some sort. We play board games. They play on the playground after school, so yeah, I just enjoy seeing them enjoy each other.
01:01
[The woman looks into the camera. She walks down the stairs.]
VO Laura: I was diagnosed in 2021 with early breast cancer, HR+, HER2-negative, node positive. I went and they started doing the mammograms, and I could tell as they were doing them,
01:17
[The woman sits in a chair and explains her situation directly to the camera.]
Laura: that the series of images they were trying to get was getting more and more precise and detailed, so I could tell they had located something and then the radiologist walked in. And I looked at her, we had masks on, and so I just really see her eyes and they start to water up, and she does this all day long, so I said, "So this is like really serious, right?" And she was like, "You're going to be okay, but you're just going to have to walk a really hard road for a while."
01:53
[The woman looks at her reflection in the bathroom mirror. She is somber, and heartbroken.]
VO Laura: I started treatment less than three weeks after finding my lump and active treatment lasted almost a year.
02:06
[The woman sits in a chair, speaking to the camera. Before it cuts to the woman walks into the bathroom and picks up Verzenio. She opens the box and places the medication into a separate container. Picking up a glass of water she talks her medication.]
Laura: I first discussed Verzenio after surgery with my oncologist. I was eager to take it.
Caption: Verzenio + hormone therapy showed a 35% reduction in the risk of cancer returning, compared with hormone therapy alone. In a study, 85.5% of people taking Verzenio + hormone therapy were alive without their cancer returning vs 78.6% taking hormone therapy alone. Data was assessed at 48 months; the study is ongoing to see if there is a survival benefit.
02:15
[The woman sits in a chair and speaks directly to the camera. The woman turns on the faucet and washes her hands. And then runs her fingers through her hair. Styling her hair as she looks at her reflection in the mirror.]
Laura: My first thought was, "I will do Verzenio if it increases the odds that I will not have to go through all these treatments again, that my kids won't have to hear me say again, that it's come back."
Caption: 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.
2:26
Caption: 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.
2:31
[The woman sits in a chair and speaks directly to the camera. She's a little more emotional than before, tears swell in her eyes.]
Laura: So it wasn't, "Will I or won't I take it?" It was, "How will we manage it?"
Caption: 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.
02:34
[People silhouettes watching home videos. The woman sits on the couch in the dark eating popcorn and watching home videos on a projector with her three children.]
VO Josh: I remember when Verzenio was on the table and the thing for me that was most helpful was she showed me this data set. That, for me, was just like all I needed to know.
Caption: If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away.
2:43
[A man sits in a chair and tell us his story directly to camera.]
Josh: Like, yes obviously we're going to do this because every one of those percentage points matters. It matters for me. It matters for our kids.
02:51
[A projection of a young boy plays on the screen. The woman watches memories of her children.]
VO Laura: For us as parents, I know some people love their kids as kids, but I've just really always been thinking about who they would be as adults, and I want to see that.
3:03
[Objects in the woman's house “nevertheless she persisted.” and photographs of her children.]
Laura: Josh and I have been brave enough to book some trips in the future.
03:08
[Montage of things in their home; a cross stitch, more family photographs.]
VO Laura: We're taking a 15th anniversary trip to Europe,
03:12
[Woman sits in a chair, speaking to the camera.]
Laura: In a few months, and we feel confident enough to do that.
03:17
[The woman looks at her husband while they sit on the front porch, smiling.]
VO Josh: One of the words that honestly comes to mind for me when I think of Laura is that she is a trailblazer.
03:22
[Man, shots of him talking.]
Josh: You know, Laura's very active on social media, so she finds communities of people who are in similar situations.
03:28
[The woman, man and their children sit at a dining room table and joyfully play a card game together.]
VO Josh: She just cares about that so deeply. She cares so much about taking the knowledge that she has and being able to share it with others,
03:36
[Man, shots of him talking.]
Josh: which is again, just another thing that I think is really amazing about her.
03:40
[The woman writes in her journal and takes a sip from a mug. She looks off into the distance.]
Caption: The most common side effects of taking Verzenio + hormone therapy: Diarrhea, Low white blood cell counts (neutropenia, leukopenia), Nausea, Infections, Low red blood cell counts (anemia), Decreased appetite, Headache, Hair thinning or hair loss (alopecia), Abdominal pain, Tiredness, Vomiting, Low platelet count (thrombocytopenia)
VO Laura: In the midst of the extreme decision fatigue and treatment fatigue that you're probably feeling, pause and consider what possibilities you can be creating for yourself for the future.
03:48
Caption: You should tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Verzenio. For more information, you should ask your doctor or pharmacist.
03:52
[The three children run into the playground, and the man and woman follow behind them with linked arms, watching them happily play.]
VO Laura: I would look at my life, think about what I want to be doing. If taking Verzenio twice a day, once in the morning, once a night with hormone therapy will allow you to do those things.
04:14
[Woman sits in a chair, speaking to the camera. Slow push in on woman as she talks.]
Laura: And to increase the chances that you'll be there for people you love and you'll be there for people who you don't even know yet who you will love, then it's worth it.
04:23
Indication and Safety Summary:
VO + Caption: Verzenio is used to treat certain types of breast cancer known as HR+, HER2-negative, hormone receptor positive human epidermal growth factor receptor two negative breast cancer. It is a medicine you can take if you have no 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. It is not known if Verzenio is safe and effective in children.
04:49
VO + Caption: 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 anti-diarrheal medicine such as loperamide, drink more fluids, and tell your healthcare provider right away.
05:23
VO + Caption: 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.
05:53
VO + Caption: 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.
06:18
VO + Caption: 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 healthcare provider may reduce your dose or stop your treatment. Tell your healthcare provider right away if you have any of the following signs and symptoms of liver problems: Feeling very tired, loss of appetite, pain in the upper right side of your stomach area, abdomen, 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, fast breathing, shortness of breath, fast heart rate, chest pain.
07:13
VO + Caption: Verzenio can harm your unborn baby. Use effective birth control contraception during treatment and for three weeks after the last dose of Verzenio, and do not breastfeed during treatment with Verzenio and for at least three 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, abdominal pain, infections, low red blood cell counts, anemia, decreased appetite, headache, hair thinning or hair loss, alopecia, 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.
08:12
VO + Caption: 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 medications 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.
08:45
VO + Caption: 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're 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 two doses at the same time to make up for the missed dose.
09:25
VO + Caption: 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.
09:43
VO + Caption: Learn more. Verzenio is a prescription medicine. For more information call 1-800-545-5979, or go to www.verzenio.com.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. Verzenio is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
PP-AL-US-3629 06/2023 ©Lilly USA, LLC 2023. All rights reserved.
Verzenio + hormone therapy showed a 35% reduction in the risk of cancer returning, compared with hormone therapy alone. In a study, 85.5% of people taking Verzenio + hormone therapy were alive without their cancer returning vs 78.6% taking hormone therapy alone. Data was assessed at 48 months; the study is ongoing to see if there is a survival benefit.
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