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Real-world outcomes in mTNBC (HR-/HER2-)

See how TRODELVY performed in a real-world outcome setting

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Real-World Overall Survival
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  • Real-World Overall Survival
  • Real-World Patient Characteristics
  • Real-World Safety

    • Real-world Overall Survival

    Real-world results support the proven efficacy of TRODELVY seen in the phase 3 ASCENT trial1

    A retrospective, observational cohort study assessed real-world clinical outcomes in patients with mTNBC treated with TRODELVY as 2L and later.1

    Limitations: These EHR-derived, retrospective data were not powered for statistical analysis and should be considered descriptive only. The results require cautious interpretation and could represent chance findings. Data entry errors could have occurred. It is likely there are missing data.1

    Real-world mPFS and mOS in 2L and 3L+ mTNBC1

    Real-world mPFS and mOS in 2L and 3 L+ mTNBC graphic

    aFrom index data.

    • ​For the total population (N=230), the mPFS was 3.8 months (95% CI: 3.1–4.3) and the mOS was 10 months (95% CI: 8.3–11.1)1

    Numerically greater outcomes were seen in 2L vs 3L+ in a real-world treatment setting1

    Real-world OS rate (95% CI)

    2L mTNBC (n=77) 3L+ mTNBC (n=153) Total (N=230)
    12-month 51% (37–64) 35% (26–44) 40% (33–48)
    24-month 32% (13–54) 20% (11-29) 23% (15–32)
    2L mTNBC
    (n=77)    		 3L+ mTNBC
    (n=153)    		 Total
    (N=230)
    12-month
    51%
    (37–64)    		 35%
    (26–44)    		 40%
    (33–48)
    24-month
    32%
    (13–54)    		 20%
    (11-29)    		 23%
    (15–32)

    Methods in a real-world study

    A retrospective, observational cohort study used ConcertAI database de-identified EHR data, with safety data supplemented with physicians’ notes. From April 2020 to May 2022, 230 adult female patients with mTNBC were treated with TRODELVY in the 2L or later setting. 33% and 67% of patients received TRODELVY in the 2L and 3L+ settings, respectively. The median starting dose was 10 mg/kg, with a median of 9 doses. The median treatment duration was 3.8 months among all patients and 4.2 months among 2L patients. The maximum treatment duration among all patients was 25.8 months. Data included in this analysisa were cut off in August 2022. At the end of the study period, 21 (9%) patients were still receiving TRODELVY.1,b

    bData cutoff to allow for ≥3-month data accrual. Sensitivity analysis was performed using ≥6-month data accrual.1

    Review ASCENT study design

    Real-world evidence supports proven efficacy benefit seen in ASCENT study1

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    Real-world patient characteristics

    Patients in the real-world study and ASCENT had certain characteristics that may reflect your practice1,2

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    Age

    RWE1

    Median age: 60 (IQR: 49-69 years)

    Ascent2

    Median age: 54

    (range: 27-82 years; 81% <65 years)
    Ethnicity

    Rwe1

    26% Black

    Ascent2

    12% Black
    Performance status

    Rwe1

    0–1 (70%),

    ≥2 (17%),

    Unknown (12%)

    Ascent2

    0 (43%),

    1 (57%)
    DEMOGRAPHICS (N=230)1
    Female: 100%
    Median age: 60 years (IQR: 49−69 years)
    Race/ethnicity:

    63% White

    26% Black/African American

    4% Asian

    7% Other/unknown
    Treatment provider type:

    66% Community

    27% Academic

    7% Unknown
    Disease Characteristics1
    ECOG performance status:

    0−1 (70%)

    ≥2 (17%)

    Unknown (12%)
    De novo mBC: 18%
    Median time from mBC diagnosis to starting TRODELVY treatment:

    11.8 months

    (IQR: 7.6−19.2 months)
    Brain metastases: 7%
    Visceral metastasis: 73%
    Treatment History1
    Prior anticancer regimens in the metastatic setting, median: 2 (IQR: 1−3)
    Chemotherapy drugs:

    65% Taxanes

    42% Carboplatin

    41% Capecitabine

    11% Anthracyclines

    7% Cyclophosphamide
    PARPi: 7%
    PD-1/PD-L1 inhibitors: 48%

    This real-world study included an older and more diverse patient population with worse performance status compared with patients enrolled in ASCENT1,2

    Real world Safety

    Real-world safety data (N=230)1

    Limitations: Underreporting of AEs and dose modifications in physicians’ notes may have occurred with an unknown impact on the results.2

    • Dose reduction and interruptions were observed in 34% and 58% of all patients, with 26% and 39% due to toxicity, respectively; 7% discontinued TRODELVY due to toxicity1
    • Fatigue was reported in 45%, neutropenia in 33%, and diarrhea in 30% of patients1
    • Concomitant administration of G-CSF was observed in 58% of all patients, with most of these patients (99/134=74%) having received G-CSF with prior anticancer treatment1
    • 15% of patients received G-CSF for the first time during treatment with TRODELVY1

    Explore the safety profile across indications2

    See safety data

    2L=second line; 3L+=third-line or later; AEs=adverse events; CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; EH=estrogen; EHR=electronic health record; G-CSF=granulocyte colony-stimulating factor; HER=human epidermal growth factor receptor; IQR=interquartile range; mPFS=median progression-free survival; mOS=median overall survival; mTNBC=metastatic triple-negative breast cancer; OS=overall survival; PARPi=poly (ADP-ribose) polymerase inhibitor; PD-1=programmed cell death protein 1; PD-L1=programmed cell death ligand 1; RWO=real-world outcomes.

    References: 1. Kalinsky K, Spring L, Yam C, et al. Real-world use patterns, effectiveness, and tolerability of sacituzumab govitecan for second-line and later-line treatment of metastatic triple-negative breast cancer in the United States. Breast Cancer Res Treat. 2024;208(1):203-214. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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    Indications

    TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

    • ​Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
    • Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    Important Safety Information

    Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.

    Boxed Warning: neutropenia and diarrhea
    • ​TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
    • TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
    Contraindications
    • Severe hypersensitivity reaction to TRODELVY.
    Warnings and precautions

    Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

    Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

    Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

    Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

    Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

    Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

    Adverse Reactions

    In the pooled safety population, the most common (≥25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

    In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

    In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

    Drug Interactions

    UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

    UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

    Please see full Prescribing Information, including BOXED WARNING.