Treating Breast Cancer with Trodelvy – What You Need to Know

Medically Reviewed by Patricia Weiser, PharmD on September 04, 2024
8 min read

You might have heard about Trodelvy, a medicine the FDA approved in 2021 and 2023 to treat some types of breast cancer. Trodelvy is for adults with triple-negative breast cancer (TNBC) or hormone receptor (HR)-positive, HER2-negative breast cancer (HR+/HER2-) that has spread in the body or cannot be removed by surgery.

Trodelvy is used when you've already tried at least two other treatments. Its active ingredient is sacituzumab govitecan-hziy. Avoid using Trodelvy with other medicines that have this ingredient. Check with your health care provider about all your medicines to ensure you only use one containing sacituzumab govitecan-hziy.

Below are common questions and answers about Trodelvy and whether it may be a treatment option for you.

Trodelvy treats breast cancer by targeting cells with a protein called trophoblast cell surface antigen 2 (Trop-2). 

Here’s how it works:

  1. Monoclonal antibody (finding cancer cells). Trodelvy has a part that attaches to the Trop-2 protein, which is often on breast cancer cells.
  2. SN-38 (delivering chemotherapy). Once Trodelvy sticks to the cancer cells, it delivers a strong chemotherapy drug called SN-38.
  3. Stopping cancer cell growth. Inside the cancer cell, SN-38 blocks the cell from copying its DNA, which stops it from growing and makes it die. By focusing on cancer cells, Trodelvy helps kill them while causing less harm to healthy cells.

Trodelvy is given through an IV, which delivers the medicine directly into your bloodstream. You will receive this medicine at a hospital, clinic, or infusion center. The treatment is given on day 1 and day 8 of a 21-day cycle. To better plan your schedule, know that the first session will last about 3 hours, and the ones after that will last 1 to 2 hours. Your health care provider will choose the right dose based on your weight. They’ll make sure you continue until the disease changes or if the side effects become too hard to handle. Before each treatment, you may receive other medicines to help prevent side effects like fever, nausea, or skin reactions during the IV. These can include acetaminophen, antihistamines (like diphenhydramine), and sometimes steroids.

Clinical studies were done to test how safe and effective Trodelvy is for treating certain types of breast cancer. 

One study, ASCENT, looked at how well Trodelvy worked, compared to standard chemotherapy, for people with TNBC who couldn’t have surgery. People in the study received either Trodelvy or standard chemotherapy options like capecitabine, eribulin, gemcitabine, or vinorelbine. Most of the people were White (79%), followed by Black (12%), Asian (4%), and those classified as others (5%). The median age was 54, and nearly all were female (99.6%). The study looked at how well the Trodelvy treatment worked by measuring the time people lived without the cancer getting worse (called progression-free survival, or PFS). The main focus was on people whose cancer had not spread to the brain. They also measured PFS for all patients, whether their cancer had spread to the brain, and overall survival (OS).

Another study, TROPiCS-02, involved people with HR+/HER2- metastatic breast cancer who had already tried at least two other treatments. People in the study received either Trodelvy or single-agent chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). In this study, 67% of people were White, 4% were Black, 3% were Asian, and 26% were of unknown race. The median age was 56, and almost all were female (99.6%). The main goal of the study was to see how long people lived without their cancer getting worse, or progression-free survival. Other goals were to measure overall survival (OS), safety, and quality of life.

Results from the ASCENT study showed that Trodelvy worked better than standard chemotherapy in people with TNBC. On average, people taking Trodelvy lived longer without their cancer worsening (progression-free survival) and lived longer overall (overall survival). Specifically:

  • For people without cancer in the brain (88% of all patients), the average time without cancer getting worse was 5.6 months with Trodelvy vs. 1.7 months with chemotherapy.
  • For people whose cancer had spread to the brain and was stable (12% of all patients), the average time without cancer getting worse was 2.8 months with Trodelvy vs. 1.6 months with chemotherapy.
  • People treated with Trodelvy lived for about 11.8 months, compared to 6.9 months for those receiving chemotherapy.

Similarly, in the TROPiCS-02 study with HR-positive, HER2-negative breast cancer, Trodelvy also provided greater benefits:

  • People who took Trodelvy had about 5.5 months without their cancer progressing, compared to 4 months for those on chemotherapy. 
  • People treated with Trodelvy lived 3.2 months longer than those treated with chemotherapy (14.4 months, compared to 11.2 months).
  • More patients responded to Trodelvy (21% had their tumors shrink) compared to those who received standard chemotherapy (14%) 

The time it takes for Trodelvy to show results can vary for each person. In clinical trials, some people saw their tumors shrink within the first few months. Your health care provider will monitor your progress with regular scans and tests to check how well Trodelvy works for you.

Trodelvy can cause side effects, as does any other medicine. Here are some of the common ones that can be serious and how you can manage them:

Low white blood cell count (neutropeniaincreases your risk of infections. Your health care provider will monitor your blood counts. They may adjust your dose or give you medicine to boost your white blood cells. Make sure your health care provider knows right away if you get a fever, as it might be a sign of an infection.

Diarrhea is a side effect that causes loose stools. Drink plenty of fluids and use anti-diarrheal medicine as recommended. Let your health care provider know if diarrhea is severe or doesn't go away.

Nausea and vomiting are common side effects. Avoiding strong smells, eating smaller meals, and eating more often can help ease nausea. Your health care provider may prescribe anti-nausea medicine to help. 

Fatigue. It's common to feel very tired. Rest as much as you need, and maintain a balanced diet. If approved by your health care provider, light exercise can help boost your energy.

Hair loss. You might lose some or all of your hair for a while. If this happens, you can wear a wig, scarf, or hat to feel more comfortable.

Low red blood cell count (anemia). This can make you feel weak and short of breath. Your health care provider will monitor your blood counts and may suggest treatments if necessary.

Constipation. Your health care provider might recommend stool softeners or laxatives if needed. Staying hydrated, eating high-fiber foods, and gentle exercise can help. 

Decreased appetite. Try eating smaller, nutrient-dense meals throughout the day. A nutritionist can offer advice.

Rash. If you get a rash, use gentle, fragrance-free skin care products and avoid hot showers. Your health care provider can suggest treatments if the rash becomes bothersome.

Belly pain. If you have severe or persistent pain in your belly area, let your health care provider know right away.

Pregnancy and breastfeeding. Trodelvy can harm an unborn baby, so you must use effective birth control during treatment and for 6 months after your last dose. You should not breastfeed during treatment and for at least a month after your last dose.

Reports of people's side effects are essential and are used to add information to the prescribing information used by people who prescribe medicine. These aren't all the possible side effects. If any symptoms bother you, talk to your health care provider. You can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). 

Trodelvy doesn’t have known food interactions, but drinking alcohol could make side effects like nausea, vomiting, diarrhea, and fatigue worse. Trodelvy can interact with other medicines. 

Medicines that increase Trodelvy levels. Certain medicines can increase Trodelvy levels in your body, making side effects more likely. Your health care provider may avoid prescribing these medicines with Trodelvy. 

Medicines that decrease Trodelvy levels. Some medicines can lower Trodelvy levels, making it less effective. Your health care provider will avoid these combinations.

Tell your health care provider about all your medicines, including over-the-counter medicines, vitamins, and herbal supplements.

Do not use Trodelvy if you’re allergic to it, sacituzumab govitecan-hziy, or any of its ingredients. Your pharmacist can give you a complete list of the ingredients.

Severe allergic reactions, including life-threatening ones, have happened with Trodelvy. Watch for:

  • Cardiac arrest
  • Low blood pressure
  • Wheezing
  • Swelling (especially of the face and throat)
  • Lung inflammation
  • Skin reactions

UGT1A1 gene. If you have a certain variation of this gene, you might be more likely to have side effects like low white blood cell counts. Your health care provider may test for it and adjust your treatment if necessary.

Liver problems. Trodelvy might be unsafe if you have moderate or severe liver issues. Even with mild liver problems, your health care provider must monitor you closely.

Allergies. Your health care provider might recommend a different treatment if you’re allergic to Trodelvy or its ingredients.

Pregnancy. Trodelvy is not safe during pregnancy and can harm your baby. Women should use birth control while taking Trodelvy and for 6 months after. Males with partners who can get pregnant should use birth control, such as condoms, during Trodelvy treatment and for 3 months after the last dose. 

Breastfeeding. Avoid breastfeeding while on Trodelvy for at least a month after your last dose. It’s not clear if Trodelvy passes into breast milk, but it could harm your baby.

Trodelvy is a specialized medicine typically available through specialty pharmacies. Your oncologist will prescribe Trodelvy, and your health care team will help you get the medicine and schedule your IVs. Your insurance may require prior authorization before covering Trodelvy, and your health care provider will provide the necessary information to your insurance company.

Trodelvy's maker offers support programs that may help you with the cost of treatment. These programs can provide information about insurance coverage, financial assistance, and help with reimbursement. A copay program is also available for eligible people with commercial insurance, which may help reduce out-of-pocket costs. To learn more about these assistance programs and see if you’re eligible, visit the drugmaker’s website at Trodelvy Financial Assistance or speak with your health care provider. For questions about cost, insurance coverage, or anything else, contact the drugmaker at 844-TRODELVY (844-876-3358).