Trodelvy® (sacituzumab govitecan-hziy)
Can TRODELVY be used in HR+/HER2- mBC?
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
TRODELVY® (sacituzumab govitecan-hziy)
Can TRODELVY be used in HR+/HER2- metastatic breast cancer?
This information is provided in response to your question. It is not treatment advice on how to use TRODELVY. Please discuss this question and others you have about your medical condition or treatment with your healthcare provider.
Download the TRODELVY Patient Information for more details, including approved use(s) and important warnings. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_patient_pi.pdf
The short answer1,2
In the TROPiCS-02 clinical trial, 543 people with a type of breast cancer, that was hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-), that had spread to other parts of the body (metastatic) or could not be removed by surgery, were treated with either TRODELVY or traditional chemotherapy (a treatment that kills cancer cells or stops them from dividing).
Results of the trial showed that patients lived with no sign of cancer progression, known as progression-free survival, for a median of 5.5 months when treated with TRODELVY, and 4 months when treated with chemotherapy. Median progression-free survival is how long half of the people were alive without their cancer getting worse.
Results of the trial also showed that patients lived, with or without their cancer getting worse, known as overall survival, for a median of 14.4 months when treated with TRODELVY, and 11.2 months when treated with chemotherapy. Median overall survival is the time at which half of the people were still alive after starting treatment.
The 3 most commonly reported side effects in people treated with TRODELVY in the trial were:
- low levels of white blood cells, also known as neutropenia, in 71 out of 100 people who received TRODELVY and in 55 out of 100 people who received chemotherapy.
- loose or watery stools, also known as diarrhea, in 62 out of 100 people who received TRODELVY and in 23 out of 100 people who received chemotherapy.
- Feeling sick, also known as nausea, in 59 out of 100 people who received TRODELVY and in 35 out of 100 people who received chemotherapy.
What is the most important information I should know about TRODELVY?1
Some medicines have important warnings that are designed to alert you of serious or life-threatening risks that come with taking the medicine.
TRODELVY has an important warning for: Severe diarrhea and severe or life-threatening low white blood cell count (neutropenia) as early as the first treatment cycle. Your healthcare provider should check your blood cell counts during treatment. You may receive a medicine in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever, also known as febrile neutropenia. Your healthcare provider should monitor you for diarrhea during treatment with TRODELVY and check to see if it is caused by an infection. You may receive a medicine to help control your diarrhea.
If your white blood cell count is too low or your diarrhea is severe and cannot be controlled with medicines, your healthcare provider may lower your dose of TRODELVY, delay your treatment, or permanently stop treatment.
Who is TRODELVY for?1
TRODELVY is a prescription medicine used to treat adults with:
- a type of breast cancer called HR-positive and HER2-negative (HR+/HER2-).
TRODELVY may be used:
- when your breast cancer has spread to other parts of the body, known as metastatic, or cannot be removed by surgery, and
- if you previously received endocrine therapy and two or more 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.
What is HR+/HER2- metastatic breast cancer?2
Metastatic breast cancer is where breast cells do not grow normally and form a mass, also called a tumor, that has spread to other parts of the body. A common type of breast cancer, known as being hormone receptor-positive (HR+), has one or two types of hormone receptors on the cell surface, these are estrogen and progesterone receptors. When the same cancer cells lack, or have a low amount of, the human epidermal growth factor 2 (HER2) protein they are also known as being human epidermal growth factor 2-negative (HER2-).
The HR and HER2 receptors can affect how breast cancer cells grow and what treatments may be helpful.
What did the TROPiCS-02 clinical trial tell us?1,2
In TROPiCS-02, 543 people with HR+/HER2- breast cancer which was metastatic or could not be removed by surgery were given either TRODELVY or chemotherapy, either eribulin, vinorelbine, capecitabine or gemcitabine. A total of 272 people received TRODELVY and 271 people received chemotherapy.
Everyone in the trial had previously been given, at any point in their disease, at least 1 hormone therapy, at least 1 targeted therapy known as a cyclin-dependent kinase 4/6 inhibitor, and at least 1 chemotherapy known as a taxane. Everyone had already received 2 to 4 chemotherapies for metastatic breast cancer but they did not work well or had stopped working.
TRODELVY was given by infusion into a vein, this is called intravenous or IV therapy, on day 1 and day 8 of a 21-day treatment cycle.
People could leave the trial for any reason, including: the tumor grew or spread, they could not handle side effects, decision to stop treatment, or the person died.
How long did people live without their disease getting worse?
The trial showed that some people who were given TRODELVY lived longer without their disease getting worse, known as progression-free survival, compared to those who were given chemotherapy.
How long did people live with or without their cancer getting worse?
The trial also showed that some people who were given TRODELVY lived longer, with or without their cancer getting worse, known as overall survival.
What side effects were reported in this trial?
In general, people treated with TRODELVY experienced more side effects than those treated with chemotherapy in the clinical trial. However, the number of people who had their treatment dose reduced or stopped because of side effects was similar in both groups. This means that, while treatment with TRODELVY caused more side effects than treatment with chemotherapy, most people still received their full dose of TRODELVY as planned.
What were the most common side effects in this trial?
The most common side effects in the clinical trial are summarized below:
What were the most common severe side effects in this trial?
The most common severe side effects in people who received TRODELVY are summarized below:
What serious side effects have been reported across TRODELVY clinical trials?1
The serious side effects listed below are based on what people experienced across several TRODELVY clinical trials. Side effects and their severity can be different for everyone. These are not all of the possible side effects of TRODELVY. Tell your healthcare team about any side effects you may experience.
Low white blood cell count (neutropenia) | |
| Low levels of white blood cells are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening or cause death as early as the first cycle of treatment. Your healthcare provider should check your blood cell counts during treatment with TRODELVY and may give you a medicine to help prevent low blood cell count starting in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever (febrile neutropenia).If your white blood cell count is too low, your healthcare provider may need to delay treatment or lower your dose of TRODELVY, give you a medicine called granulocyte-colony stimulating factor, also known as growth factors, to treat your low blood cell count, or in some cases may permanently stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop a 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:
|
Loose of watery stools (diarrhea) | |
| Diarrhea is common with TRODELVY and can also be severe. Severe diarrhea can lead to the loss of too much body fluid, known as dehydration, and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during treatment with TRODELVY, your healthcare provider should check to see if diarrhea may be caused by an infection. Your healthcare provider may decrease your dose, delay treatment, or permanently stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines, like loperamide (IMODIUM®) or similar. |
| Call your healthcare provider right away:
|
Allergic and infusion-related reactions | |
| TRODELVY can cause serious or life-threatening allergic and infusion-related reactions. |
| Tell your healthcare provider or nurse right away if you get any of the following symptoms of an allergic or infusion-related reaction during your infusion of TRODELVY or within 24 hours after you receive a dose of TRODELVY:
|
Nausea and vomiting | |
| 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. |
| You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive TRODELVY. 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, delay treatment, or permanently stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines. |
Glossary
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Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Anemia: low levels of red blood cells which cause tiredness and pale skin.
Antibiotic: a type of medicine that fights infections caused by bacteria.
Clinical trial: a study in people that may help to find out how well a medicine works or how safe it is.
Endocrine (hormone) therapy: a type of medicine that works by blocking or changing hormones in your body. It is often used to treat certain cancers, like some breast cancers, that rely on hormones to grow.
Hormone receptor (HR): a hormone is a substance made by a gland in your body. A receptor is a protein found inside or on the surface of a cell. When hormones attach or bind to specific receptors, it causes changes within the cell. There are 2 types of hormone receptors, estrogen and progesterone.
Human epidermal growth factor receptor (HER2): HER2 is a protein that can affect cell growth. A receptor is a protein found inside or on the surface of a cell. When proteins attach (bind) to specific receptors, it causes changes within the cell.
Leukopenia: low levels of white blood cells which can make you more at risk of infections.
References
1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Patient Information. Foster City, CA.
2. Rugo HS, Bardia A, Marmé F, et al. A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative). Future Oncol. 2024;20(11):635-651.
More information about TRODELVY
If you would like more detailed information about TRODELVY, please visit:
https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
This is the US FDA-approved Prescribing Information, including the Patient Labeling, for TRODELVY. It will tell you about the uses, warnings, and other important safety information about TRODELVY.
Important note
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. Some of the information included in this letter may not be covered in the US FDA- approved Prescribing Information for TRODELVY. Gilead Sciences, Inc. does not intend this letter to be used as medical advice and does not promote use of TRODELVY in a way that has not been approved by the FDA. Please discuss this question and others you may have about your medical condition or treatment with your healthcare provider.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or https://www.patient.askgileadmedical.com/
Reporting side effects
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
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TRODELVY GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2025 Gilead Sciences, Inc.
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