Trodelvy: Uses, Dosage & Side Effects
An antibody-drug conjugate (ADC) targeting Trop-2 for the treatment of metastatic triple-negative breast cancer and HR+/HER2− breast cancer
Trodelvy (sacituzumab govitecan) is an antibody-drug conjugate (ADC) used in the treatment of metastatic or locally advanced breast cancer. It combines a humanized anti-Trop-2 monoclonal antibody with SN-38, the active metabolite of irinotecan, to deliver targeted chemotherapy directly to cancer cells expressing the Trop-2 protein. Trodelvy is approved for triple-negative breast cancer (TNBC) after at least two prior therapies, and for hormone receptor-positive (HR+), HER2-negative breast cancer after endocrine therapy and at least two prior systemic therapies. It is administered as an intravenous infusion in a supervised healthcare setting and requires a prescription. Trodelvy has shown significant improvements in progression-free survival and overall survival in pivotal clinical trials, representing a major advance for patients with limited treatment options.
Quick Facts: Trodelvy
Key Takeaways
- Trodelvy (sacituzumab govitecan) is an antibody-drug conjugate that targets the Trop-2 protein on cancer cells, delivering the chemotherapy agent SN-38 directly to the tumor while aiming to spare healthy tissues.
- It is approved for two types of metastatic breast cancer: triple-negative breast cancer (TNBC) after at least two prior therapies, and hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer after endocrine therapy and at least two prior systemic treatments.
- Severe neutropenia and diarrhea are the most clinically significant side effects; patients require regular blood count monitoring and should report diarrhea promptly to their healthcare team.
- Treatment is given as an intravenous infusion on days 1 and 8 of a 21-day cycle at a dose of 10 mg/kg body weight; the first infusion takes 3 hours, with subsequent infusions over 1–2 hours.
- Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose; men must use contraception for 3 months after treatment ends.
What Is Trodelvy and What Is It Used For?
Trodelvy contains the active substance sacituzumab govitecan, which belongs to an innovative class of anticancer medications known as antibody-drug conjugates (ADCs). ADC technology represents one of the most significant advances in targeted cancer therapy over the past decade, combining the precision of a monoclonal antibody with the cell-killing power of a cytotoxic drug. In Trodelvy, the antibody component is a humanized immunoglobulin that specifically recognizes and binds to trophoblast cell-surface antigen 2 (Trop-2), a transmembrane glycoprotein that is highly expressed on the surface of many solid tumor cells, including the majority of breast cancers.
Trop-2 (also known as TACSTD2 or EGP-1) is a cell surface protein that plays a role in cell growth, proliferation, and migration. While Trop-2 is expressed at low levels on some normal epithelial tissues, it is significantly overexpressed on many cancer types, making it an attractive therapeutic target. In breast cancer, Trop-2 overexpression is found in approximately 85–95% of triple-negative breast cancers and 75–85% of hormone receptor-positive breast cancers, which explains why Trodelvy is effective across multiple breast cancer subtypes.
Once the antibody portion of Trodelvy binds to Trop-2 on the cancer cell surface, the entire ADC complex is internalized into the cell through receptor-mediated endocytosis. Inside the cell, the proprietary CL2A hydrolyzable linker connecting the antibody to the cytotoxic payload is cleaved, releasing SN-38. SN-38 is the active metabolite of irinotecan and a potent inhibitor of topoisomerase I, an enzyme essential for DNA replication and transcription. By trapping topoisomerase I-DNA complexes, SN-38 causes single-strand DNA breaks that convert to irreversible double-strand breaks during DNA replication, ultimately triggering apoptotic cell death. Notably, Trodelvy has a high drug-to-antibody ratio (DAR) of approximately 7.6, meaning each antibody molecule carries a large payload of SN-38, enhancing its anticancer potency.
An important feature of Trodelvy’s design is the moderately labile CL2A linker, which allows some SN-38 to be released in the tumor microenvironment even before the ADC is internalized. This “bystander effect” means that neighboring cancer cells that may express lower levels of Trop-2 can also be affected, potentially enhancing the overall antitumor activity. However, this same property also contributes to some of the systemic side effects observed with treatment.
Trodelvy is approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and regulatory authorities in numerous other countries for the following indications:
- Metastatic triple-negative breast cancer (mTNBC): Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies, with at least one of them for advanced disease. The landmark ASCENT trial (a randomized phase III study) demonstrated that Trodelvy significantly improved median progression-free survival (5.6 months vs. 1.7 months) and median overall survival (12.1 months vs. 6.7 months) compared to single-agent chemotherapy of the physician’s choice.
- Hormone receptor-positive, HER2-negative (HR+/HER2−) metastatic breast cancer: Trodelvy is indicated for adult patients with unresectable locally advanced or metastatic HR+/HER2− breast cancer who have received endocrine-based therapy and at least two additional systemic therapies for advanced disease. The TROPiCS-02 trial showed that Trodelvy improved both progression-free survival and overall survival in this heavily pretreated population, with a median overall survival of 14.4 months compared to 11.2 months with physician’s choice chemotherapy.
Triple-negative breast cancer accounts for approximately 10–15% of all breast cancers and is defined by the absence of estrogen receptor (ER), progesterone receptor (PR), and HER2 expression. TNBC tends to be more aggressive than other subtypes, with higher rates of recurrence and fewer targeted treatment options. HR+/HER2− breast cancer is the most common subtype, representing about 70% of all breast cancers, but patients whose disease progresses after endocrine therapy and multiple lines of chemotherapy have limited effective options. Trodelvy has filled an important unmet need for both of these patient populations.
Trodelvy is designed to target cancer cells expressing the Trop-2 protein, which is overexpressed on most breast cancers. Unlike some ADCs with stable linkers, Trodelvy’s moderately labile CL2A linker allows a bystander killing effect in the tumor microenvironment, potentially increasing antitumor activity. However, because Trop-2 is also expressed at low levels on some normal tissues, and due to the bystander effect, side effects such as neutropenia and diarrhea can occur and require careful management.
What Should You Know Before Receiving Trodelvy?
Contraindications
Trodelvy must not be administered to patients who have a known hypersensitivity to sacituzumab govitecan or to any of the excipients in the formulation (2-(N-morpholino)ethanesulfonic acid (MES), polysorbate 80, and trehalose dihydrate). If you suspect that you may be allergic to any of these components, you should discuss this with your healthcare provider before starting treatment. Allergic reactions to previous infusions of Trodelvy are also a contraindication to further administration, and your oncologist will assess the risk-benefit balance before any re-challenge.
Warnings and Precautions
Neutropenia: Trodelvy can cause severe neutropenia, a condition in which the number of neutrophils (a type of white blood cell critical for fighting infections) drops dangerously low. Neutropenia is one of the most common and potentially life-threatening side effects of Trodelvy, particularly during the early cycles of treatment. Severe neutropenia increases the risk of serious infections, including febrile neutropenia and neutropenic sepsis, which can be fatal. Your healthcare team will perform regular blood tests to monitor your neutrophil counts before each dose. If neutrophil levels fall below a certain threshold on day 1 or day 8 of any treatment cycle, your dose will be delayed. Your doctor may also prescribe granulocyte colony-stimulating factors (G-CSF) to help stimulate white blood cell production. Seek immediate medical attention if you develop fever (temperature of 38.5°C or higher), chills, sore throat, mouth sores, abdominal pain, pain near the rectum, painful urination, diarrhea, cough, or shortness of breath during treatment.
Severe or life-threatening neutropenia may occur with Trodelvy. Your doctor will check your blood counts before each dose. Seek emergency medical care immediately if you develop a fever of 38.5°C (101.3°F) or higher, chills, or signs of infection during treatment.
Diarrhea: Trodelvy can cause severe diarrhea that may lead to dehydration and acute kidney injury. Diarrhea should be treated promptly with loperamid (unless you have an infection). Your healthcare team may also prescribe prophylactic atropine before subsequent infusions to help manage cramping and early-onset diarrhea. If you experience severe diarrhea, your treatment will be delayed until symptoms improve. Tell your doctor immediately if you notice dark-colored urine or decreased urine output, as these may be signs of dehydration requiring intravenous fluids.
Nausea and vomiting: Trodelvy commonly causes nausea and vomiting, which can be severe in some patients. Your doctor will prescribe anti-emetic medications (anti-nausea drugs) before each Trodelvy infusion and between treatment sessions to help control these symptoms. Treatment with Trodelvy will not proceed if nausea and vomiting are severe and uncontrolled; symptoms must be adequately managed before the next dose can be given.
Infusion-related reactions: Some patients may experience infusion-related reactions during or shortly after Trodelvy administration. These reactions can range from mild symptoms such as flushing and chills to severe or life-threatening events including anaphylaxis. Before each infusion, you will receive premedication to reduce the risk of these reactions (typically an antipyretic, an antihistamine, and a corticosteroid). During the infusion and for 30 minutes afterward, you will be closely monitored. If you experience symptoms such as itching, rash, fever, shaking, sweating, difficulty breathing, chest pain, or rapid heartbeat, alert your healthcare team immediately. The infusion rate may be slowed or the infusion stopped entirely if a severe reaction occurs.
UGT1A1*28 gene variant: Some patients carry a genetic variant called UGT1A1*28, which affects how the body metabolizes SN-38, the active component released by Trodelvy. Patients who are homozygous for this variant (meaning they have two copies of the gene) break down SN-38 more slowly, leading to higher circulating levels of the drug. This results in an increased susceptibility to certain side effects, particularly neutropenia (with or without fever) and anemia. If you are known to carry the UGT1A1*28 variant, your oncology team will monitor you especially closely throughout your treatment course, and dose adjustments may be considered.
Inform your healthcare provider if you have liver problems, kidney problems, are of childbearing potential, are taking any other medications (including over-the-counter drugs and supplements), or have experienced problems with previous infusions of any kind.
Pregnancy and Breastfeeding
Pregnancy: Trodelvy must not be used during pregnancy. Based on its mechanism of action and the known effects of SN-38, sacituzumab govitecan may cause harm to the developing fetus. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, you must inform your doctor immediately. Pregnancy testing should be performed before starting treatment.
Contraception: Women of childbearing potential must use effective contraception during treatment with Trodelvy and for at least 6 months after the last dose. Men whose female partners could become pregnant must use effective contraception during treatment and for at least 3 months after the last dose of Trodelvy.
Breastfeeding: Do not breastfeed during treatment with Trodelvy and for at least 1 month after the last dose. It is not known whether sacituzumab govitecan or SN-38 passes into breast milk, but given the potential for serious adverse reactions in nursing infants, breastfeeding must be discontinued during therapy.
Fertility: Based on nonclinical findings, Trodelvy may impair fertility in both males and females. Discuss fertility preservation options with your healthcare team before starting treatment if future parenthood is important to you.
Driving and Using Machines
Trodelvy may affect your ability to drive and use machines. Side effects such as dizziness and fatigue have been reported in patients receiving this medication. If you experience these symptoms, you should exercise caution when driving vehicles or operating machinery until you know how Trodelvy affects you.
Children and Adolescents
Trodelvy should not be given to children and adolescents under 18 years of age. The safety and efficacy of sacituzumab govitecan have not been established in the pediatric population, and there is no relevant use for this medication in children for the approved breast cancer indications.
How Does Trodelvy Interact with Other Drugs?
Trodelvy releases SN-38 as its cytotoxic payload. SN-38 is primarily metabolized by the enzyme UGT1A1, and its pharmacokinetics can be significantly affected by medications that inhibit or induce this and related metabolic pathways. Understanding these drug interactions is essential for safe and effective use of Trodelvy, and you should always inform your oncologist about all medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements.
Drugs That May Increase Trodelvy’s Effects (UGT1A1 Inhibitors)
Certain medications inhibit the UGT1A1 enzyme, which is responsible for breaking down SN-38 in the body. When these drugs are taken alongside Trodelvy, SN-38 levels may increase, raising the risk of adverse effects such as severe neutropenia and diarrhea. Your healthcare team will carefully monitor you if any of these drugs are medically necessary.
Drugs That May Decrease Trodelvy’s Effects (Enzyme Inducers)
Certain medications can increase the metabolism of SN-38, potentially reducing the effectiveness of Trodelvy. If possible, alternative medications should be considered during Trodelvy treatment.
| Drug | Category | Effect | Clinical Significance |
|---|---|---|---|
| Propofol | UGT1A1 inhibitor (anesthetic) | Increases SN-38 levels | Increased risk of side effects; inform anesthesiologist |
| Ketoconazole | UGT1A1 inhibitor (antifungal) | Increases SN-38 levels | Increased risk of neutropenia and diarrhea |
| Tyrosine kinase inhibitors (-nibs) | UGT1A1 inhibitor (anticancer) | Increases SN-38 levels | Close monitoring for toxicity required |
| Carbamazepine | Enzyme inducer (antiepileptic) | Decreases SN-38 levels | May reduce Trodelvy efficacy; consider alternatives |
| Phenytoin | Enzyme inducer (antiepileptic) | Decreases SN-38 levels | May reduce Trodelvy efficacy; consider alternatives |
| Rifampicin | Enzyme inducer (anti-TB) | Decreases SN-38 levels | May significantly reduce Trodelvy efficacy |
| Ritonavir | Enzyme inducer (antiretroviral) | Decreases SN-38 levels | May reduce efficacy; consult HIV specialist |
| Tipranavir | Enzyme inducer (antiretroviral) | Decreases SN-38 levels | May reduce efficacy; consult HIV specialist |
Always tell your oncologist about all medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements. Even medications that seem unrelated to cancer treatment can interact with Trodelvy and affect its safety or effectiveness.
What Is the Correct Dosage of Trodelvy?
Trodelvy is always administered by a physician or nurse experienced in the use of anticancer therapies, in a hospital or clinic setting equipped to manage infusion-related reactions and other potential complications. Before starting treatment, your healthcare team will confirm your suitability for Trodelvy through blood tests and clinical assessment. You will also receive premedication before each infusion to reduce the risk of infusion-related reactions, nausea, and vomiting.
Adults
The standard dosing schedule for Trodelvy in adult patients with breast cancer is based on a 21-day (3-week) treatment cycle. The recommended dose is 10 mg/kg of body weight, calculated at the start of each cycle. Trodelvy is administered on day 1 and day 8 of each cycle. Treatment continues until disease progression or unacceptable toxicity, as determined by your oncologist.
Standard Adult Dosing
Dose: 10 mg/kg body weight
Schedule: Day 1 and Day 8 of each 21-day cycle
Route: Intravenous infusion
First infusion: Over 3 hours
Subsequent infusions: 1–2 hours (if first infusion was uneventful)
Duration of treatment: Until disease progression or unacceptable toxicity
| Day | Dose | Infusion Time | Monitoring |
|---|---|---|---|
| Day 1 (first cycle) | 10 mg/kg | 3 hours | During infusion + 30 min after |
| Day 8 (first cycle) | 10 mg/kg | 1–2 hours | During infusion + 30 min after |
| Days 9–21 | No treatment | N/A | Rest period |
| Day 1 (subsequent cycles) | 10 mg/kg | 1–2 hours | During infusion + 30 min after |
Children
Trodelvy is not approved for use in children and adolescents under 18 years of age. No clinical studies have been conducted in pediatric patients for the approved breast cancer indications.
Elderly
No specific dose adjustment is required for elderly patients based on age alone. However, older patients may be more susceptible to certain side effects such as neutropenia and diarrhea. Your oncologist will closely monitor your tolerance to treatment and may adjust the dose if needed based on your overall health and any adverse effects experienced.
Missed Dose
If you miss an appointment for a Trodelvy infusion, contact your healthcare team to reschedule as soon as possible. Do not wait until your next planned visit, as maintaining the dosing schedule is important for treatment effectiveness. Your oncologist will determine the best approach to continue your treatment if a dose has been missed.
Overdose
Because Trodelvy is administered by a healthcare professional in a supervised clinical setting, the risk of overdose is very low. In the unlikely event that too much medication is given, your medical team will monitor you closely and provide supportive treatment as needed. There is no specific antidote for sacituzumab govitecan overdose; treatment would be symptomatic, focusing on managing side effects such as neutropenia and diarrhea.
Dose Modifications for Side Effects
Your oncologist may need to adjust your Trodelvy dose if you experience certain side effects. Dose reductions are typically made in decrements (from 10 mg/kg to 7.5 mg/kg, and then to 5 mg/kg if further reduction is needed). If side effects persist at the lowest dose level, your doctor may decide to discontinue Trodelvy permanently. Common reasons for dose modification include severe neutropenia, febrile neutropenia, severe diarrhea, severe nausea and vomiting, and other grade 3 or 4 adverse events.
Breast cancer treatment with Trodelvy typically requires multiple treatment cycles. Do not discontinue treatment early without discussing it with your oncologist, even if your symptoms improve. Stopping treatment prematurely may allow the cancer to progress.
What Are the Side Effects of Trodelvy?
Like all medicines, Trodelvy can cause side effects, although not everybody experiences them. It is important to be aware of both common and serious side effects so you can report them promptly to your healthcare team. Early recognition and management of adverse effects is crucial for maintaining your quality of life during treatment and for ensuring that your treatment course can continue as planned.
Serious Side Effects
Seek immediate medical attention if you experience any of the following serious adverse effects, which may be life-threatening:
Severe neutropenia: Fever (38.5°C or higher), chills, sweating, sore throat, mouth sores, abdominal pain, pain near the rectum, painful or frequent urination, diarrhea, cough, or shortness of breath.
Severe diarrhea: Multiple watery stools per day, especially with signs of dehydration such as dark urine, decreased urine output, dry mouth, or dizziness.
Severe allergic/infusion reactions: Swelling of lips, tongue, eyes, throat, or face; widespread hives; difficulty breathing; wheezing; chest tightness; rapid heartbeat; feeling faint.
Side Effects by Frequency
Very Common
May affect more than 1 in 10 patients
- Neutropenia (low neutrophil count), including febrile neutropenia
- Anemia (low red blood cell count)
- Leukopenia and lymphopenia (low white blood cell counts)
- Diarrhea
- Nausea
- Vomiting
- Fatigue and tiredness
- Hair loss (alopecia)
- Decreased appetite
- Constipation
- Abdominal pain
- Rash and itching
- Back pain, joint pain
- Urinary tract infections (burning urination, frequent urge)
- Upper respiratory tract infections (cough, sore throat, runny nose)
- Shortness of breath (dyspnea)
- Dizziness
- Sleep problems (insomnia)
- Low blood potassium or magnesium levels
Common
May affect up to 1 in 10 patients
- Sepsis (serious blood infection with fever, chills, pale skin, shortness of breath)
- Pneumonia (lung infection)
- Thrombocytopenia (low platelet count, leading to bleeding and bruising)
- Sinusitis (nasal congestion, facial pain)
- Influenza-like symptoms, oral herpes infection
- High blood sugar
- Dehydration
- Low blood phosphate, calcium, or sodium levels
- Anxiety
- Altered taste (dysgeusia)
- Low blood pressure
- Nosebleeds, postnasal drip with cough
- Colitis (inflammation of the intestines)
- Mouth inflammation, upper abdominal pain, acid reflux, bloating
- Skin darkening, acne-like skin problems, dry skin
- Chest wall muscle pain, muscle spasms
- Blood in urine, excess protein in urine
- Chills
- Weight loss
- Elevated alkaline phosphatase or lactate dehydrogenase levels
Uncommon
May affect up to 1 in 100 patients
- Enteritis (inflammation of the small intestine)
If any of these side effects become severe or troublesome, or if you notice any new symptoms not listed here, contact your healthcare team promptly. Your oncologist can adjust your dose, delay treatment, or prescribe supportive medications to help manage side effects. Do not attempt to manage serious side effects at home without medical guidance.
It is important to report any suspected side effects to your healthcare provider. Reporting helps improve the understanding of a medicine’s safety profile and allows regulatory authorities to continuously monitor the benefit-risk balance. You can also report side effects directly to your national pharmacovigilance authority.
How Should Trodelvy Be Stored?
Trodelvy is stored and administered exclusively by healthcare professionals in a hospital or clinic setting. Patients do not need to handle or store this medication at home. However, understanding the storage requirements may be helpful for informational purposes.
- Unopened vials: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Light protection: Keep the vial in the outer carton to protect it from light.
- Shelf life: Do not use after the expiry date printed on the vial label and carton (after “EXP”). The expiry date refers to the last day of the stated month.
- After reconstitution and dilution: The prepared infusion bag can be stored refrigerated at 2°C to 8°C for up to 24 hours, protected from light, if not used immediately. After removal from the refrigerator, the diluted solution should be administered at room temperature (up to 25°C) within 8 hours, including the infusion time.
- Visual inspection: Do not use the reconstituted solution if it appears cloudy or discolored. The properly reconstituted solution should be clear and yellow.
- Keep out of reach of children.
Trodelvy is a cytotoxic medication. Special procedures for handling and disposal must be followed by healthcare personnel in accordance with local guidelines for hazardous drugs.
What Does Trodelvy Contain?
Understanding the composition of your medication can be helpful, particularly if you have known allergies or sensitivities to specific pharmaceutical excipients. Trodelvy is supplied as a lyophilized (freeze-dried) powder in glass vials, which must be reconstituted and diluted by healthcare professionals before administration.
Active Ingredient
Each vial contains 200 mg of sacituzumab govitecan. After reconstitution with 20 ml of sodium chloride 0.9% injection solution, each ml of the reconstituted solution contains 10 mg of sacituzumab govitecan. Sacituzumab govitecan is an antibody-drug conjugate consisting of a humanized anti-Trop-2 IgG1 kappa monoclonal antibody conjugated to SN-38 via a CL2A linker, with an average drug-to-antibody ratio (DAR) of approximately 7.6.
Excipients (Inactive Ingredients)
- 2-(N-morpholino)ethanesulfonic acid (MES): A buffering agent used to maintain the pH of the formulation during storage.
- Polysorbate 80: A surfactant that helps stabilize the protein in solution and prevents aggregation during reconstitution.
- Trehalose dihydrate: A sugar (lyoprotectant) that protects the antibody-drug conjugate during the freeze-drying process and helps maintain stability.
Appearance and Packaging
Trodelvy is an off-white to yellowish powder for concentrate for solution for infusion, supplied in a glass vial. Each pack contains one vial. The reconstituted solution should appear clear and yellow. Do not use the medication if the solution is cloudy, contains visible particles, or is discolored.
Manufacturer
Trodelvy is manufactured by Gilead Sciences Ireland UC, located in Carrigtohill, County Cork, Ireland. Gilead Sciences holds the marketing authorization for Trodelvy in the European Union and many other markets worldwide.
Frequently Asked Questions About Trodelvy
Trodelvy (sacituzumab govitecan) is an antibody-drug conjugate used to treat metastatic or locally advanced breast cancer. It is approved for two indications: triple-negative breast cancer (TNBC) in patients who have received at least two prior systemic therapies (with at least one for advanced disease), and hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer in patients who have received endocrine-based therapy and at least two prior systemic therapies for advanced disease. The cancer must be unresectable (cannot be removed by surgery) because it has spread locally or to other parts of the body.
Trodelvy is given as an intravenous (IV) infusion in a hospital or clinic by a healthcare professional. It is administered on day 1 and day 8 of each 21-day treatment cycle, at a dose of 10 mg per kilogram of body weight. The first infusion takes approximately 3 hours. If the first infusion is well tolerated, subsequent infusions may be given over 1 to 2 hours. Patients are monitored during each infusion and for 30 minutes afterward for any reactions.
UGT1A1*28 is a genetic variant that affects the UGT1A1 enzyme, which is responsible for metabolizing (breaking down) SN-38, the active chemotherapy component released by Trodelvy. Patients who are homozygous for UGT1A1*28 (have two copies of this variant) metabolize SN-38 more slowly, resulting in higher blood levels of the drug. This increases the risk of certain side effects, particularly neutropenia (with or without fever) and anemia. Patients known to carry this variant are monitored more closely during treatment, and dose adjustments may be considered by their oncologist.
No, Trodelvy must not be used during pregnancy as it may harm the developing baby. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. Men whose partners could become pregnant must use contraception during treatment and for 3 months afterward. Breastfeeding must also be avoided during treatment and for at least 1 month after the last dose, as it is unknown whether the drug passes into breast milk.
Trodelvy is an antibody-drug conjugate (ADC), which means it combines the targeting ability of a monoclonal antibody with the cell-killing power of a chemotherapy drug. The antibody component specifically recognizes the Trop-2 protein on cancer cell surfaces, allowing the drug (SN-38) to be delivered directly to the tumor cells. This is different from traditional chemotherapy, which circulates throughout the entire body and affects both healthy and cancerous cells indiscriminately. While Trodelvy can still cause side effects (because Trop-2 is expressed on some normal tissues), its targeted approach aims to concentrate more of the drug at the tumor site.
Two landmark clinical trials established the efficacy of Trodelvy. The ASCENT trial (a phase III randomized study) demonstrated significant improvements in both progression-free survival and overall survival for patients with metastatic triple-negative breast cancer compared to standard chemotherapy. The TROPiCS-02 trial (also phase III) showed that Trodelvy improved overall survival in patients with HR+/HER2− metastatic breast cancer who had received multiple prior therapies. Both trials were published in the New England Journal of Medicine and formed the basis for regulatory approval by the FDA and EMA.
References
- European Medicines Agency (EMA). Trodelvy (sacituzumab govitecan) – Summary of Product Characteristics. Last updated 2025. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Trodelvy (sacituzumab govitecan-hziy) – Prescribing Information. Revised 2024. Available at: FDA Labels
- Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer (ASCENT trial). N Engl J Med. 2021;384(16):1529–1541. doi:10.1056/NEJMoa2028485
- Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02). J Clin Oncol. 2023;41(20):3608–3618. doi:10.1200/JCO.22.02564
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Breast Cancer. Version 2.2025.
- Cardoso F, Paluch-Shimon S, Senkus E, et al. ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with metastatic breast cancer. Ann Oncol. 2024;35(6):573–597.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023.
- Goldenberg DM, Cardillo TM, Govindan SV, et al. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate. Mol Cancer Ther. 2015;14(6):1356–1365.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, breast cancer, and clinical pharmacology.
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