Trodelvy® (sacituzumab govitecan-hziy)
Real-World Data in mTNBC

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Trodelvy® (sacituzumab govitecan-hziy)

Real-World Data in mTNBC

This document is in response to your request for information regarding Trodelvy® (sacituzumab govitecan-hziy [SG]) and real-world data in metastatic triple-negative breast cancer (mTNBC).

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Relevant Product Labeling1

SG is indicated for the treatment of adult patients with unresectable locally advanced or mTNBC who have received ≥2 prior systemic therapies, ≥1 of them for metastatic disease.

Real-World Data on SG Use in mTNBC

This document summarizes realworld evidence on SG in mTNBC from multiple studies, focusing on patient characteristics, line of therapy (LOT), efficacy, and safety. It is not intended to be comprehensive; additional real-world evidence summaries are available for specific topics, including antibody-drug conjugate sequencing, use in Asian patients, and neutropenia incidence and management.

Summaries of real-world studies that evaluated SG use in patients with mTNBC are shown in Table 1.2-21

 


Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Table 1. Real-World Studies of Patients With mTNBC2-21

Region and Data Source

Pt Characteristics

SG Setting/
Prior LOT

Effectiveness Outcomes

Safety Outcomes

Retrospective cohort database study2

England; Cancer Analysis System database (data sources: Systemic AntiCancer Therapy database, Cancer Outcomes and Services Dataset, and Office of National Statistics)

N=980; female, 100%

2L cohort (n=606)

  • Age, mean ± SD: 2L, 53.7±11.9 y; 3L, 53.1±11.4 y
  • ECOG PS 0 and 1,a n (%): 2L, 177 (29) and 276 (46), respectively;
    3L, 67 (11) and 115 (19)

3L cohort (n=374)

  • Age, mean ± SD:
    2L 55±12.6 y;
    3L, 55.4±12.7 y
  • ECOG PS 0 and 1,a n (%):
    2L, 140 (37) and 168 (45), respectively;
    3L, 106 (28) and 171 (46)

SG LOT: 
2L, n=606

3L, n=374

3L was composed of two subcohorts: 3La (Stage I or II, or resectable Stage III TNBC) and 3Lm (unresectable Stage III or de novo Stage IV TNBC)

mPFS (95% CI), mo:

2L, 2.53 (2.3–2.76)

3L, 2.43 (2.2–2.76)

mOS (95% CI), mo:

2L, 6.7 (6.14–7.62)

3L, 5.54 (4.9–6.14)

Results are available for 3L subcohorts

Safety data not reported

Retrospective, observational, multicenter study3,4

Canada; pt support program

N=453

  • Age, mean (IQR): 57 (49–‍66) y

SG LOT:

2L, 29.4%

3L, 42.8%

4L, 16.6%

5L+, 11.3%

Treatment duration, median (95% CI), mo: 4.2 (3.7–4.9)

Effectiveness data not reported

Treatment modifications:

  • Treatment delays, 78.4%
  • Number of delays, median (range): 3 (1–‍18)
  • Duration of delays (n=355), median (IQR): 23 (9–49) d
  • ≥1 dose reduction, 55%

SG DCs (including DCs due to AEs), n (%): Pt decision, 12 (3.7);
Physician decision, 10 (3.1)

Retrospective study5

US; Integra Connect PrecisionQ database

N=409; female, 99.3%

  • Age, median (range): 61 (28–‍89) y
  • ECOG PS 0–1, n (%): 286 (69.9)
  • Metastatic sites, n (%):
    visceral (lung or liver), 300 (73.4);
    bone, 216 (52.8);
    brain, 87 (21.3)

SG LOT, n (%):

2L, 192 (46.9)

3L, 128 (31.3)

4+, 89 (21.8)

SG used in multiple LOTs, 21 (5.1)

Follow-up, median (range), mo:

10 (0.6–51.3)

mPFS (95% CI), mo:

  • 5 (4.4–5.5)
  • 3-mo rate: 66.8 (62–71.2)
  • 6-mo rate: 42.4 (37.5–‍47.2)

mOS (95% CI), mo:

  • 11.3 (10–12.8)
  • 12-mo rate: 47.5% (42.4–‍52.4%)
  • 24-mo rate: 22.5% (17.8–‍27.5%)

mTTNTD (95% CI), mo: 6 (5.3–‍6.6)

Most common AEs: fatigue, 47.4%; diarrhea, 38.1%; neutropenia, 34.7%; nausea, 32%

Treatment modifications:

  • Dose reduction rate, 43.1% (no appreciable differences by LOT)
  • Dose delay (by ≥7 d), 65%
  • Time to the first dose delay, median (range) d: 13.5 (1–682)
  • Of pts with dose delay, 51.9%, 11.3%, 9%, and 27.8% had their first dose delay in Cycle 1, 2, 3, and 4+, respectively

Neutropenia, n (%): 281 (68.7);
median time to onset: 8 d

G-CSF use, n (%): 247 (60.4)

  • Primary prophylaxis, 88 (21.5)
  • Secondary prophylaxis, 112 (27.4)
  • Treatment for neutropenia, 47 (11.5)

Retrospective, observational cohort study6

US; Flatiron Health database

N=381; female, 99%

  • Age, median (IQR): 61 (52–69) y
  • ECOG PS 0–1, n (%): 247 (65)
  • Brain metastasis (of pts with ≥1 metastasis site), n/N (%): 68/291 (23)

SG LOT, n (%):

2L, 118 (31)

3L+, 263 (69)

Follow-up, median (IQR), mo:
8.7 (4.5–14.6)

mOS (95% CI), mo:

  • 11.3 (10–12.9)
  • 12-mo rate: 47% (41–‍52%)
  • 24-mo rate: 19% (14–‍25%)

mTTNTD (95% CI), mo: 5.6 (5–‍6.4)

Treatment modifications:

Dose reductions, n/N (%): 137/308 (44)

Neutropenia, n (%):

  • Grade 2, 94 (25); Grade 3/4, 101 (27)

G-CSF use, n (%):

  • Any concomitant use, 225 (59)
  • Grade 3/4 neutropenia with GCSF, 10%
  • Of pts who received GCSF prophylaxis, Grade 3/4 neutropenia occurred in 4% with primary prophylaxis, 33% who received GCSF as treatment, and 13% who received no GCSF

Retrospective cohort study7

Poland/Czech Republic/Slovakia (14 centers)

N=249; female, 100%

  • Age, median (IQR): 53 (46–‍63) y

Prior LOTs, median (IQR):

2 (1–2)

Follow-up, median (IQR), mo:
7.82 (4.29–12.01)

Outcome (95% CI), mo:

mPFS, 4.1 (2.9–5.3)
mOS, 10.3 (9.4–11.2)

ORR: 31.4%

Treatment modifications

Delays, 60.2%

Dose reductions, 41.5%

Retrospective, observational cohort study8

US; ConcertAI Patient 360™ and physician notes

N=230; female, 100%

  • Age, median (IQR):
    60 (49–69) y
  • ECOG PS 0–1, n (%): 162 (70)
  • Metastatic sites, n (%):
    visceral, 167 (73);
    brain, 17 (7)

SG LOT:

2L, 33%

3L+, 67%

Follow-up, median: 7.2 mo

mOS (95% CI), mo:

  • 2L+, 10 (8.3–11.1)
  • 2L, 13.9 (9.8–NE)
  • 3L+, 8.4 (7.7–10.3)

mPFS (95% CI) mo:

  • 2L+, 3.8 (3.1–4.3)
  • 2L, 4.9 (2.9–6)
  • 3L+, 3.5 (2.7–4.2)

mTTNTD (95% CI), mo:

  • 2L+, 4.6 (3.9–5.3)
  • 2L, 4.8 (3.2–6.9)
  • 3L+, 4.4 (3.8–5.5)

Toxicities: Fatigue, 45%; neutropenia, 33%; and diarrhea, 30%

Toxicity led to, n (%):

SG DC, 17 (7);
SG dose reduction, 59 (26);
SG treatment interruption, 89 (39)

G-CSF use, n (%):

  • Prior to SG treatment, 99 (43)
  • First use during SG treatment, 35 (15)

Time from SG initiation to G-CSF use (among pts receiving G-CSF during SG use), median (IQR): 8.5 (8–29) d

Retrospective, observational, SACISUR study9,21

Spain

(18 hospitals)

N=159; female, 100%

  • Age, median (IQR): 53 (21–‍77) y
  • Metastatic sites, n (%):
    visceral, 120 (76.9);
    CNS, 22 (13.8)

Previous LOT, median (range): 3 (2–‍8)

SG LOT:

1L, 3.8%

2L, 41.5%

3L+, 54.1%

Follow-up, median: 11.6 mo

Outcome (95% CI), mo:

mPFS, 4.6 (3.7–6.3)
mOS, 10.9 (7.6–14.2)

ORR (CR or PR): 31.2%

DCR: 68.9%

Results are available for BMPos cohort

Most common AEs (Grade 3/4):

  • Neutropenia, 59.4% (30.4%)
  • Diarrhea, 49% (8.2%)
  • Nausea, 45.3% (0.6%)
  • ALT/AST elevation, 24.5% (1.9%)

AEs led to:

  • ≥1 SG dose reduction: 43.4%
  • SG DC: 5.7%

G-CSF use:

  • Primary prophylaxis, 29.6%
  • Secondary prophylaxis, 17.6%

Retrospective study10,11

Italy

(11 centers)

N=149; female, 100%

  • Age, median (range): 53 (26–‍80) y
  • ECOG PS 0–1: 96%
  • Metastatic sites, n (%): lymph nodes, 97 (65.1); lung, 75 (50.3); bone, 74 (49.7)

Prior anticancer regimens in metastatic setting median (range): 2 (0–‍7)

Follow-up, median: 18.2 mo

Outcome (95% CI) mo:

mPFS, 5.75 (4.37–7.13)

mOS, 12.8 (10.8–15.9)

ORR: 40% (all were PR)

Select TRAEs, any grade (Grade 3/4):

  • Neutropenia, 53% (26.2%)
  • Anemia, 50.3% (0.7%)
  • Nausea, 50.3% (0%)
  • Diarrhea, 40.9% (3.4%)

SG dose decreased, 34.9%

SG DC, 4%

Retrospective study12

UK

(16 centers)

N=132; female, 99.2%

  • Age, median (range): 56 (28–91) y
  • ECOG PS 0–1, n (%): 115 (87.5)
  • Metastatic sites, n (%): nodal, 102 (77); visceral, 99 (75); bone, 63 (48); liver, 61 (46); CNS, 24 (18)

Prior LOT in metastatic setting, median: 2

SG LOT:

2L, 28%

3L 31%

3L+, 41%

Survival analysis population, n=126

mPFS (95% CI) mo:

  • 5.2 (4.5–6.6)
  • 1L/2L, 5.3 (4.4–7)
  • 3L+, 5 (3.7–6.4)

mOS (95% CI), mo:

  • 8.7 (6.8–NA)
  • 1L/2L, NR
  • 3L+, 8.7 (6.8–11.2)

Most common AEs, all grade (Grade 3/4):

  • Fatigue, 82% (14%)
  • Neutropenia, 55% (29%)
  • Diarrhea, 58% (15%)
  • Nausea, 38% (3%)

Treatment modifications due to AEs led to
SG dose reduction, 54%

SG DC, 5%

Retrospective and prospective, observational SARELIFE study13

Italy

(30 centers)

N=128; female, 100%

  • Age median (range): 58 (30–‍86) y
  • ECOG PS, n (%):
    0, 78 (60.9); 1, 37 (28.9)
  • Metastases at diagnosis, n (%): overall, 32 (25);
    lymph nodes, 89 (69.5);
    bone, 54 (42.2); lung, 54 (42.2); liver, 37 (28.9); CNS, 16 (12.5); pleura, 15 (11.7)

Prior LOT, median (range): 2 (0–‍9)

1 or 2 prior LOTs: 67.2%

>2 prior LOTs: 32.8%

Follow-up, median: 12.7 mo

Outcome (95%CI), mo: mPFS, 5.9 (4.5–‍6.8)
mOS, 14.6 (11.7–‍17)

ORR: 31.9%

Best response (evaluable, n=116):

CR, 0.9%; PR, 31%;
SD, 38.8%; PD, 29.3%

Most common AEs (safety analysis, n=122):

  • Neutropenia, 51.2%
  • Fatigue, 47.6%
  • Nausea, 43.9%
  • Diarrhea, 34.1%
  • Anemia, 28%
  • Febrile neutropenia, 6.1%

Grade 3 pneumonitis, n=1

Dose reductions, n=46

AEs led to SG DC, n=4

Time to first dose reduction, median (range): 32 (7–205) d

Retrospective study14,15

France

(8 centers)

N=127

  • Age, median (range) at metastasis (n=117): 53 (25–‍80) y
  • Visceral metastases, n (%): 77 (60.6)

Prior LOT in metastatic setting, median (range): 2 (0–‍11)

Follow-up, median (95% CI), mo: 10.4 (8.3–11.2)

Outcome (95% CI), mo:

mPFS, 4.1 (3.7–4.7)

mOS, 9.7 (7.1–12.2)

Best response (n=116):

CR, 2.6%; PR, 33.6%; SD ≥6 mo, 39.7%; PD, 24.1%

Safety data not reported

Retrospective, single-center study16

US; Memorial Sloan Kettering Cancer Center

N=126; female, 99%

  • Age, median (range): 52 (27–86) y
  • Metastatic sites, n (%):
    visceral, 88 (70);
    CNS, 29 (23)

Prior LOT in metastatic setting, median (range): 2 (0–‍8)

Outcomes (range), mo:

mPFS, 3 (0–13)
mOS, 6 (0–33)

Most common AEs:

  • Hematologic, 18%
  • Gastrointestinal, 11%
  • Fatigue, 9%

AEs led to SG dose reduction, 31%

Retrospective study17

US

(4 centers)

N=115; female, 100%

  • Age, median (range): 60 (31–85) y
  • ECOG PS, median (range):
    1 (0–2)
  • Metastatic sites, n (%):
    bone, 64 (55.7);
    lung, 62 (53.9);
    liver, 58 (50.4);
    lymph nodes, 55 (47.8);
    brain, 25 (21.7)

Prior LOT in metastatic setting, n (%):

≤3L, 81 (70.4)

>3L, 34 (29.6)

Follow-up, median: 16.1 mo

mOS (95% CI), mo:

  • 9.6 (7.8–12.9)
  • 1-yr rate: 43% (33–‍52%)

mPFS (95% CI), mo:

4.8 (3.6–5.9)

ORR: 27.8%

CR, 1%; PR, 26.8%; SD for ≥6 mo, 35%; PD, 37.1%

Most common (≥20%) any grade AEs, (Grade 3/4):

  • Neutropenia, 68% (41%)
  • Anemia, 71% (31%)
  • Fatigue, 57% (10%)
  • Nausea, 38% (8%)
  • Diarrhea, 38% (8%)
  • Febrile neutropenia, 23% (6%)
  • Constipation, 20% (0)

AEs led to, n (%):

SG dose reduction, 58 (51.3)

SG DC, 15 (13.2)

G-CSF use, n (%):

After starting SG, 54 (47)

Primary support, 26 (22.6)

Secondary prophylaxis, 28 (24.3)

Multicenter TRACIE study18

Australia

EAP and reimbursed pts; interim analysis (17 sites)

N=112

  • Age, median (IQR): 54.5 (49.5–‍64.5) y;
  • ECOG PS 0–1: 71.5%
  • Most common metastatic sites:
    lymph nodes, 58.9%;
    liver, 42%; lung, 29.5%

Prior LOT in metastatic setting:

≥2L, 62.5%

Follow-up, median: 25.3 mo

Outcome (95% CI), mo:

mPFS, 9.5 (8.4–11.5)
mOS, 13.1 (9.5–17.5)
mTTNT, 6.2 (5.2–8)

Most common AEs:

  • Diarrhea, 9.8%
  • Neutropenia, 5.4%
  • Fatigue, 4.5%

Toxicities led to:

  • SG dose reduction, 23.3%
  • SG DC, 9.8%

AEs that led to SG DC: nausea (4.5%); neutropenia (3.6%); and anemia, fatigue, and diarrhea (each, 2.7%).

G-CSF use: primary prophylaxis, 7.1%; secondary prophylaxis, 32.1%

Ambispective, bicentric cohort study19

France

EAP

N=103; female, 100%

  • Age, median (range): 55 (26–‍89) y
  • ECOG PS 0–1, n (%): 83 (80.6)
  • Metastatic sites, n (%):
    visceral, 82 (79.6);
    liver, 45 (43.7); brain, 32 (31.1)

Prior LOT in advanced setting, n (%):

1–2L, 66 (64.1)
>2L, 37 (35.9)

Follow-up, median: 9.6 mo

Outcome (range), mo:

mPFS, 4 (3.5–5.3)
mOS, 9.2 (7.2–NR)

ORR, n (%): 31 (30.1)

  • CR, 2 (1.9)
  • PR, 29 (28.2)

Results available for BMPos pts

Toxicity led to, n/N (%):

  • SG DC, 1/78 (1.3)
  • SD dose reduction, 19/103 (16.4)

Most common toxicities that led to SG dose reduction, n/N (%):

  • Hematological, 8/19 (42.1)
  • Gastrointestinal, 6/19 (31.6)
  • Febrile neutropenia, 3/19 (26.3)

Retrospective, observational study: TROPSPAIN20

Spain

Cohort 1 (SG in
the Special Situation Medication program; 18 sites)

N=87; female, 100%

  • Age, median (IQR): 51 (44–‍61) y
  • ECOG PS 0–1, n (%): 58 (66.7)
  • Most common metastatic sites, n (%):  
    lymph nodes, 41 (47.1);
    bone, 37 (42.5);
    lung, 33 (37.9)

SG LOT:

2L, 26.4%

3L in 24.1%

≥4L in 49.4%

Number of prior LOT median (IQR):

2 (1–4).

Interim analysis

Follow-up, median (IQR), mo: 9.2 (5.2–‍15.3)

Outcome (95% CI), mo:

mOS, 9.3 (7.7–12.3)
mTTNTD, 4.5 (3.7–5.7)

AEs of interest, any grade (Grade 3/4):

Diarrhea,b 46.7% (5.4%)

Neutropenia, 44% (54.9%)

Any-grade AE led to, n (%):

  • SG DC, 1 (1.3)
  • SG dose reduction, 24 (32)
  • SG treatment interruption, 26 (36.7)

G-CSF use for prophylaxis, n/N (%): primary, 14/33 (42.4); secondary, 19/33 (57.6)

Abbreviations: 1L/2L/3L/4L=first-/second-/third-/fourth-line; 2L+/3L+/4L+/5L+=second-/third-/fourth-/fifth-line or later; AE=adverse event; BC=breast cancer; BMNeg=negative for brain metastases; BMPos=positive for brain metastases; CNS=central nervous system; CR=complete response; DC=discontinuation; DCR=disease control rate; EAP=Early Access Program; ECOG PS=Eastern Cooperative Oncology Group Performance Status; G-CSF=granulocyte colonystimulating factor; HR=hazard ratio; LA=locally advanced; LOT=line of therapy; mOS=median overall survival; mPFS=median progressionfree survival; mTNBC=metastatic triplenegative breast cancer; mTTNTD=median time to next treatment or death; NA=not available; NE=not estimable; NR=not reached; ORR=objective response rate; OS=overall survival; PD=progressive disease; PFS=progression-free survival; PR=partial response; SD=stable disease; pt=patient; SG=sacituzumab govitecan-hziy; TNBC=triple-negative breast cancer; TPC=treatment of physician’s choice; TRAE=treatment-related adverse event.

aECOG PS was missing/unknown at BC diagnosis in 377, 254, 211, and 43 pts in the 2L, 3L combined, 3La, and 3Lm cohorts, respectively; at initiation in 78 and 45 pts in the 2L and 3L combined cohorts; and at initiation of 3L in 394 pts in the 2L cohort.

bGrade was unknown in 2 pts (3.6%) who reported diarrhea.

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Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

References

1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.

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4. Tanguay PL, Wang M, Winson Y, Cheung A, Cumaraswamy A, P D. Real-world use of sacituzumab govitecan in the management of metastatic triple-negative breast cancer through a Canadian patient support program [Abstract P3-12-05]. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX.

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8. Kalinsky K, Spring L, Yam C, et al. Realworld use patterns, effectiveness, and tolerability of sacituzumab govitecan for secondline and laterline treatment of metastatic triplenegative breast cancer in the United States. Breast Cancer Res Treat. 2024;208(1):203-214.

9. Falcón-González A, Llabrés-Valenti E, Fernando H-C, et al. SACISUR, results of a real-world evidence observational study of the use of sacituzumab govitecan (SG) in triple negative metastatic breast cancer (mTNBC) clinical practice in the south of Spain [Poster P2-10-02]. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX.

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11. Caputo R, Piezzo M, Martinelli C, et al. Sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer patients: a multicenter real-world updated analysis [Abstract 354P]. Presented at European Society For Medical Oncology (ESMO) Breast Cancer Congress; May 14-17, 2025; Munich, Germany.

12. Hanna D, Merrick S, Ghose A, et al. Real world study of sacituzumab govitecan in metastatic triple-negative breast cancer in the United Kingdom. Br J Cancer. 2024;130(12):1916-1920.

13. Cona MS, Fiorio E, Catania G, et al. SARELIFE: an Italian, multicentric real-world study of sacituzumab govitecan in pretreated metastatic triple-negative breast cancer patients [Poster P3-12-07]. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX.

14. Arnedos M, Segier B, Vincent N, et al. Prognostic value of androgen receptor expression in patients with advanced triple-negative metastatic breast cancer treated with sacituzumab govitecan: a French multicentre retrospective study [Abstract 483P]. Presented at: European Society For Medical Oncology (ESMO) Breast Cancer Congress; May 11-13, 2023; Berlin, Germany.

15. Arnedos M, Segier B, Vincent N, et al. Prognostic value of androgen receptor expression in patients with advanced triple-negative metastatic breast cancer treated with sacituzumab govitecan: A French multicentre retrospective study [Poster: 6099]. Presented at: European Society For Medical Oncology (ESMO) Breast Cancer Congress; May 11-13, 2023; Berlin, Germany.

16. Walsh E, Klar M, Abuhadra N, Mai N, Robson M, J D. Aspire to ASCENT: Real-world outcomes from patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan in a single academic institution [Poster 419P]. Presented at: European Society for Medical Oncology (ESMO) Congress; 20-24 October, 2023; Madrid, Spain.

17. Alaklabi S, Roy AM, Zagami P, et al. Real-world clinical outcomes with sacituzumab govitecan in metastatic triple-negative breast cancer. JCO Oncol Pract. 2025;21(5):620-628.

18. Wong V, Kim G, Antill YC, et al. Trodelvy use in advanced triple negative breast cancer in Australia (TRACIE): study design and interim analysis [Abstract e13130]. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL.

19. Loirat D, De Moura A, Korbi S, et al. Sacituzumab govitecan in metastatic triple negative breast cancer: efficacy -with a focus on brain metastases- and toxicity in a real-world cohort [Poster 216P]. Presented at: ESMO Breast Cancer Congress; May 11-13, 2023; Berlin, Germany.

20. Bermejo de las Heras B, Abad MF, Tormo SB, et al. Sacituzumab govitecan (SD) in patients with previously treated unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) within routine clinical practice in Spain (TROPSPAIN): interim analysis of retrospective, observational, multicentre study [Poster 513]. Presented at: European Society For Medical Oncology (ESMO) Breast Cancer Congress; May 14-17, 2025; Munich, Germany.

21. Falcón-González A, Llabrés-Valenti E, Henao-Carrasco F, et al. Real-world effectiveness and safety of Sacituzumab Govitecan in metastatic triple-negative breast cancer: results from the multicenter retrospective observational SACISUR cohort in Southern Spain. Front Oncol. 2026;16:1717135. https://www.ncbi.nlm.nih.gov/pubmed/41815552

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Follow-Up

For any additional questions, please contact Trodelvy Medical Information at:

1888-983-4668 or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety 1-800-445-3235, option 3 or
https://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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The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.

It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact gilead.privacy@gilead.com.

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