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).

This document summarizes real‑world evidence on SG in mTNBC from multiple studies (N≥50), 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.

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, as a single agent, is indicated for the first-line (1L) treatment of adult patients with unresectable locally advanced or mTNBC who are not candidates for programmed death (ligand) 1 inhibitor-based therapy.

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

Summaries of real-world studies that evaluated SG use in patients with mTNBC are shown in Table 1.2-22

 

 


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 mTNBC2-22

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 Anti‑Cancer 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 were 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 Precision‑Q 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/secondary prophylaxis, 88 (21.5)/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, n/N (%):

Dose reductions, 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 G‑CSF, 10%
  • Of pts who received G‑CSF prophylaxis, Grade 3/4 neutropenia occurred in 4% with primary prophylaxis, 33% who received G‑CSF as treatment, and 13% who received no G‑CSF

Retrospective, observational, multicenter study:  TROPSPAIN7

 

Spain

(20 sites)

N=288; female, 98.6%

  • Age, median (IQR): 54 (46–‍62) y
  • ECOG PS 0–1/≥2, n (%): 197 (86.4)/31 (13.6)

Metastatic sites, n (%): lymph nodes, 144 (62.9); bone, 118 (51.5); lung, 97 (42.4); liver, 85 (37.1); brain, 20 (8.7)

SG LOT, n (%):

2L, 86 (29.9)

3L, 77 (26.7)

≥4L, 125 (43.4)

Follow-up, median (IQR), mo:

  • 9 (4.7–15.1)

Outcome (95% CI), mo:

  • rwOS: 9.6 (8.3–‍11.1)
  • rwTTNTD: 4.6 (4.1–‍5)

 

rwOS by LOT, median (95% CI) mo:

  • 2L, 10 (8.6-13.4)
  • 3L, 9.6 (6.8-12.1)
  • ≥4L, 8.6 (7.4-11)

 

rwTTNTD by LOT, median (95% CI) mo:

  • 2L, 5.5 (4.2-7)
  • 3L, 4.7 (3.5-5.8)
  • ≥4L, 4.2 (3.4-4.7)

 

Any AEs: n=241 (83.7%)

AESIs, n (%):

  • Diarrhea, 104 (43.1)
  • Neutropenia, 88 (36.5)

Grade, n (%):

  • Grade 1 (mild), 585 (54.8)
  • Grade 2 (moderate), 334 (31.3)
  • Grade 3 (severe), 126 (11.8)
  • Grade 4 (life-threatening), 19 (1.8)
  • Grade 5 (death), 3 (0.3)b

AEs led to, n (%):

  • Dose reductions, 64 (26.6)
  • Interruption, 77 (31.9)
  • SG DC, 6 (2.5)

G-CSF use:

Administered in 123 (42.7%) patients;

total administrations (N=905):

  • Primary/secondary prophylaxis, 61.4%/38.6%

Multicenter observational analysis8

 

Italy

(18 centers)

 

N=271; n=76 LTRs (defined as rwPFS ≥9 mo; includes n=60 [78.9%] 9–18 mo and n=16 [21.1%] ≥18 mo)

  • Age, median (range): 56 (range 32–80) y
  • ECOG PS 0/1/2, n (%):
    45 (59.2)/30 (39.5)/1 (1.3)
  • mTNBC, n=56 (73.7%)

SG LOT, n (%):

1L, 3 (3.9)

2L, 26 (34.2)

≥3L, 47 (61.8)

 

Follow-up, median, mo:

  • 19.4

Outcome, median (95% CI), mo:

rwPFS, 14 (13.3–16.7)

rwOS, 25.6 (21.0–NR)

ORR, 67.1%

  • CR, n=1 (1.3)
  • PR, n=50 (65.8%)
  • SD, n=24 (31.6%)
  • PD, n=1 (1.3%)

 

rwPFS by LOT, median (95% CI) mo:

  • 2L vs ≥3L: 6.7 (5–8.4) vs 6.2 (4.7–7.3) (P=0.28)

Safety data were not reported

Retrospective cohort study9

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 study10

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 study11,12

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/secondary prophylaxis, 29.6/17.6

Retrospective study13,14

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%)

Treatment modifications, %:

SG dose decreased, 34.9

SG DC, 4

Multicenter TRACIE study15

 

Australia EAP and/or Pharmaceutical Benefits Scheme

 

(19 sites)

aTNBC; N=143

  • Age, mean (standard deviation): 55.1 (11.9) y; n=34 (24%) ≥65 y
  • ECOG PS 0/1/2+/unknown, n (%): 80 (56)/24 (17)/6 (4)/ 33 (23)
  • Metastatic sites, n (%): nodal, 94 (66); bone, 75 (52); lung, 60 (42); liver, 54 (38); brain, 25 (18)

SG LOT, n (%):

1L, 7 (4)

2L, 48 (34)

≥3L, 40 (28)

≥4L, 48 (34)

 

Follow-up, median: 11.1 mo

Survival outcomes (95% CI):

  • mPFS, 5.3 mo (4.6–6.7)
  • mOS, 11.5 mo (8.5–14.4)

OS by LOT, (2L [N=48] vs ≥3L [N=88]), moc:

  • 17.3 vs 10 (HR=0.74; P=0.12)

Dose reduction due to toxicity, n=34 (24%)

Toxicities that led to dose reduction, n (%):

  • Diarrhea, 16 (11)
  • Fatigue, 10 (7)
  • Neutropenia, 6 (4)

Dose reductions per patient, 1/2/≥3,

 n (%): 27 (19)/15 (11)/7 (5)

Most common toxicities leading to SG

DC:

  • Fatigue (n=5)
  • Diarrhea (n=4)
  • Neutropenia (n=4)
  • Anemia (n=3)
  • Nausea (n=3)
  • Constipation (n=2)

G-CSF use, n (%):

Primary/secondary prophylaxis, 39 (27)/17 (12)

Retrospective study16

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%)

AEs led to:
SG dose reduction, 54%

SG DC, 5%

Retrospective and prospective, observational SARELIFE study17

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 study18,19

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 were not reported

Retrospective, single-center study20

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 that led to SG dose reduction, 31%

Retrospective study21

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)

Ambispective, bicentric cohort study22

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)

Abbreviations: 1L/2L/3L/4L=first-/second-/third-/fourth-line; 2L+/3L+/4L+/5L+=second-/third-/fourth-/fifth-line or later; AE=adverse event; AESI=adverse event of special interest; aTNBC=advanced triple-negative breast cancer; BC=breast cancer; 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 colony‑stimulating factor; HR=hazard ratio; LOT=line of therapy; LTR=long-term responder; mOS=median overall survival; mPFS=median progression‑free survival; mTNBC=metastatic triple‑negative breast cancer; mTTNT=median time to next treatment; 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; rwOS=real-world overall survival; rwPFS=real-world progression-free survival; rwTTNTD=real-world time to next treatment or death; SD=stable disease; pt(s)=patient(s); Q1/Q3=quartile 1/quartile 3;SG=sacituzumab govitecan; TNBC=triple-negative breast cancer; 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.

bOf the 3 patients who died, 2 events were due to neutropenia. One of these events was considered treatment

  related, and the patient was not treated with G-CSF. The third death was due to pulmonary embolism.

c7 patients treated with SG in the 1L were excluded from this analysis.

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

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References

  1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.
  2. Chang L, Hall P. S, Preger L, et al. Real-world treatment patterns and outcomes among 2nd line (2L) and 3rd line (3L) metastatic triple-negative breast cancer (TNBC) patients (pts) in England using the Cancer Analysis System (CAS) [Poster #1075]. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2022; Chicago, IL.
  3. 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 [Poster P3-12-05]. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX.
  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.
  5. Gorantla V, Choksi R, Kudrik F, et al. Real-world sacituzumab govitecan treatment patterns and outcomes in second-line or later metastatic triple negative breast cancer: leveraging electronic health records and manual curation of a US database [Poster 31]. Presented at: Miami Breast Cancer Conference; March 6-9, 2025; Miami, FL.
  6. Nanda R, Yam C, Spring L, et al. Management of neutropenia and effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer treated in real-world settings in the United States [Poster P1-09-17]. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX.
  7. Puy MB, Bianch MA, Carrasco FH, et al. Sacituzumab govitecan (SG) in patients with previously treated unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) within routine clinical practice in Spain. Results from the retrospective, observational, multicentre TROPSPAIN study [Poster 442P]. Presented at: European Society for Medical Oncology Breast Cancer (ESMO BC); 6-8 May, 2026; Berlin, Germany.
  8. Caputo R, Buono G, Martinelli C, et al. Long-Term Responders to Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer: Real-World Outcomes and Predictors from a Multicenter Italian Cohort [Abstract #1129]. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 29-June 2, 2026; Chicago, IL.
  9. Pieniazek M, Puskulluoglu M, Polakiewicz-Gilowska A, et al. Real-world outcomes of sacituzumab govitecan in metastatic triple-negative breast cancer: an international multicentre cohort from Poland, the Czech Republic and Slovakia [Poster 566P]. European Soceity for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin, Germany.
  10. 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.
  11. 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.
  12. 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.
  13. 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 [Poster 354P]. Presented at European Society For Medical Oncology (ESMO) Breast Cancer Congress; May 14-17, 2025; Munich, Germany.
  14. 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.
  15. Wong V, Morton C, Antill Y, et al. Real World Sacituzumab Govitecan (SG) use and outcomes in Advanced Triple Negative Breast Cancer (aTNBC) in Australia (TRACIE) [Poster 484P]. Presented at: European Society for Medical Oncology Breast Cancer (ESMO BC); 6-8 May, 2026; Berlin, Germany.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
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