(BPT) - One of the worst things a woman can hear is: “You have cancer.”
The unfortunate reality is that one in every eight women in the U.S. is diagnosed with breast cancer at some point in their life. In fact, breast cancer is the most common kind of cancer nationally, and there are different subtypes. The most common subtype is HR+/HER2- breast cancer.
What Does HR+/HER2- Mean for the Women Who Have It?
Most breast cancers are distinguished by the presence or absence of certain receptors that play a role in driving their growth. These most commonly include hormone receptors (HR) – estrogen or progesterone – and human epidermal growth factor receptor 2 (HER2), which are involved in certain processes that allow the cancer cells to grow. Breast cancers that test positive for HR (“HR+”) and negative for HER2 (“HER2-”) have hormone receptors but have little to no HER2 receptors.
Thousands of women each year will be diagnosed with HR+/HER2- in early stages and may survive – and will likely live for years beyond their diagnosis.
But it's women who have metastatic breast cancer, or cancer that has spread beyond breast tissue, who need more help. For these women, their life expectancy is much shorter, and treatment may continue for the rest of their life.
“Researchers estimate that there are more than 150,000 women in the U.S. living with metastatic breast cancer,” said Laura Carfang, Executive Director at SurvivingBreastCancer.org. “Unlike women who have earlier stage breast cancer who aim to say, ‘I am a survivor,’ ‘I am cancer-free’ or ‘I have no evidence of disease,’ women with metastatic breast cancer may say, ‘I am living with cancer,’ or ‘I have no evidence of active disease.’”
For these women, tomorrow becomes uncertain without treatment options.
Metastatic Breast Cancer Requires More
Stage IV breast cancer, or metastatic disease, is when cancer cells break away from the original tumor in the breast and travel to other parts of the body. Nearly 1 in 3 people diagnosed with early-stage breast cancer will develop metastatic disease.
Once cancer is metastatic, surgery to remove the tumor or the breasts themselves is unlikely to get rid of all the cancer. People with HR+/HER2- metastatic breast cancer typically receive treatments called endocrine-based therapies that target and try to block the activity of the hormone receptors driving the cancer growth. Despite how successful these treatments may be, resistance often develops, which means they could stop working.
“Women living with metastatic HR+/HER2- metastatic breast cancer have a unique and challenging experience,” said Carfang. “Endocrine-based therapies may work for them initially, but then, after possibly many successful years of being stable, it comes back or starts growing again, and suddenly they are left asking, ‘What now? What will my next line of treatment be and what options do I have?’ We have had so little to offer for these women who have endured so much.”
Historically, once women stop responding to endocrine-based therapy, treatment has been limited to single-agent chemotherapy. Many of these women will cycle through multiple chemotherapies and may decide to discontinue treatment.
“It can feel like time is running out,” said Carfang.
Treatment Options for HR+/HER2- Metastatic Breast Cancer Are Expanding
A recent FDA approval provides a new option for certain adults with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy® (sacituzumab govitecan-hziy) is a different kind of treatment called an antibody-drug conjugate (ADC) that is approved for adults with HR+/HER2- breast cancer that has spread to other areas of the body (metastatic) or cannot be removed by surgery, and who have received endocrine therapy and at least two additional treatments for metastatic disease. It is not known if Trodelvy is safe and effective in people with moderate or severe liver problems or in children.
Trodelvy is a new option in HR+/HER2- metastatic breast cancer for women who want to continue treatment.
Please click to see Important Facts about Trodelvy, including Important Warnings for low white blood cell count and diarrhea.
If you or someone you know has HR+/HER2- metastatic breast cancer that is resistant to endocrine-based therapies and has received at least 2 additional treatments for metastatic disease, speak with your doctor about potential treatment options, including Trodelvy. For more information, please visit www.trodelvy.com/.
IMPORTANT SAFETY INFORMATION
TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:
- Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
- Severe diarrhea. Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your healthcare provider should check to see if it may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
- Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.
Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.
Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; or chills or shaking chills (rigors).
Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.
Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you:
- have been told that you carry a gene for UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
- have liver problems.
- are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.
- Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
- Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
- are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.
The most common side effects of TRODELVY include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.
These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WHAT IS TRODELVY?
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease.
It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
Please click to see Important Facts about Trodelvy, including Important Warning.
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