Table 5 Current and upcoming clinical trials of antibody drug conjugates in breast cancer

Sacituzumab govitecan (SG)

NCT01631552

IMMU-132-01

Bardia

2019

Phase I/II

Previously treated

mTNBC

108

SG

ORR 33.3% (95% CI 24.6–43.1)

DOR 7.7 mo (4.9–10.8)

PFS 5.6 mo (4.1–6.3)

OS 13 mo (11.2–13.7)

NCT02574455

ASCENT

Bardia

2021

Phase III

 > First line

a/mTNBC

468

Arm A: SG

Arm B: physician's choice

PFS 4.8 vs 1.7 mo, HR 0.41 (95% CI 0.33–0.52)

OS 11.8 vs 6.9 mo, HR 0.51 (0.42–0.63)

ORR 35% vs 5%

NCT03901339

TROPiCS-02

Rugo

2022

Phase III

Previously treated

HR+ /HER2- MBC

543

Arm A: SG

Arm B: physician's choice

PFS 5.5 vs 4.0 mo, HR 0.66 (95% CI 0.53–0.83)

OS 14.4 vs 11.2 mo, HR 0.79 (0.65–0.96)

NCT04448886

SACI-IO HR+ 

Garrido-Castro

2024

Phase II

Previously treated

HR+ /HER2- MBC

110

Arm A: SG + Pembrolizumab

Arm B: SG

PFS 8.4 vs. 6.2 mo, HR 0.76 (95% CI 0.47–1.23)

PD-L1 + PFS 11.05 vs 6.68 mo, HR 0.62 (0.29–1.36)

OS data immature

NCT03424005

MORPHEUS

Schmid

2023

Phase Ib/II

First line

Advanced/Metastatic

CD8 IHC ≥ 10%

42

Arm A: SG + Atezolizumab

Arm B: Nab-Paclitaxel + Atezolizumab

ORR 76.7% (95% CI 57.8–90.1) vs. 66.7% (29.9–92.5)

CBR 83.3% (65.3–94.4) vs. 66.7% (29.9–92.5)

PFS 12.2 mo vs. 5.9 mo, HR 0.27 (0.11–0.70)*

NCT04230109

NeoSTAR

Spring

2024

Phase II

Neoadjuvant

TNBC

50

Cohort 1: SG

pCR 30% (95% CI 18%-45%)

ORR 64% (77&-98%)

Higher KI-67 and TILs predictive of pCR with SG

Trastuzumab emtansine (T-DM1)

NCT01196052

Krop

2012

Phase II

Heavily pretreated

HER2 + MBC

110

T-DM1

ORR 34.5% (95% CI: 26.1–43.9)

CBR 48.2% (38.8- 57.9)

mPFS 6.9 mo (4.2–8.4)

mDOR 7.2 mo (4.6-NE)

NCT00509769

Burris

2011

Phase II

Previously treated

HER2 + MBC

112

T-DM1

ORR 25.9% (95% CI: 18.4–34.4)

mPFS 4.6 mo (3.9–8.6)

NCT03032107

Waks

2022

Phase Ib

> First Line

HER2 + MBC

20

Pembrolizumab + T-DM1

ORR 20% (95% CI 5.7–43.7); PFS 9.6 mo (2.8–16.0)

NCT02605915

GO29381

Hamilton

2021

Phase Ib

Any

HER2 + MBC

73

Arm A: Atezolizumab + Trastuzumab + Pertuzumab

Arm B: Atezolizumab + T-DM1

Arm C: Atezolizumab + Trastuzumab, Pertuzumab, and Docetaxel

Arm A: ORR 33%

Arm B: ORR 35%

Arm C: ORR 100%

NCT02924883

KATE2

Emens

2020

Phase II

> First line

HER2 + MBC

202

Arm A: T-DM1 + Atezolizumab

Arm B: T-DM1 + Placebo

PFS 8.2 (95% CI 5.8–10.7) vs 6.8 mo (4.0–11.1), HR 0.82 (0.55–1.23)

PD-L1 + PFS 8.5 mo (5.7-NE) vs. 4.1 mo (2.7–11.1), HR 0.60, (0.32–1.11)

Unblinded early for futility and safety in atezolizumab arm

NCT00679341

Hurvitz

2011

Phase II

First line

HER2 + MBC

137

Arm A: trastuzumab + docetaxel

Arm B: T-DM1

PFS 9.2 vs 14.2 mo, HR 0.59 (95% CI: 0.36–0.97)

ORR 58.0% vs 64.2%

NCT00829166

EMILIA

Verma

2012

Phase III

> First line

HER2 + MBC

991

Arm A: T-DM1

Arm B: Lapatinib and Capecitabine

ORR 43.6% vs 30.8%

PFS 9.6 vs 6.4 mo, HR 0.65 (95% CI 0.55–0.77)

OS 29.9 vs 25.9 mo, HR 0.75 (0.64–0.88)

NCT01120184

MARIANNE

Perez

2017

Phase III

First line

HER2 + MBC

1095

Arm A: Taxane + Trastuzumab

Arm B: T-DM1 + Placebo

Arm C: T-DM1 + Pertuzumab

PFS: 13.7 vs 14.1 vs 15.2 mo

PFS T-DM1 vs control: HR 0.91 (95% CI 0.73–1.13)

PFS T-DM1 + pertuzumab vs control: HR 0.87 (0.69–1.08)

ORR: 67.9% vs 59.7% vs 64.2%

NCT01419197

THE3RESA

Krop

2014

Third line

HER2 + MBC

602

Arm A: T-DM1

Arm B: treatment of physician's choice

PFS 6.2 vs 3.3 mo, HR 0.528 (95% CI 0.422–0.661)

OS 22.7 vs 15.8 mo, HR 0.68 (0.54–0.85)

NCT01772472

KATHERINE

Von Minckwitz

2019

Phase III

Residual disease

Adjuvant HER2 + 

1486

Arm A: T-DM1

Arm B: Trastuzumab

3-year iDFS 88.3% vs 77.0%, HR 0.50 (95% CI 0.39–0.64)

7-year iDFS 80.8% vs 67.1%

7-year OS 89.1% vs 84.4%

Trastuzumab deruxtecan (T-DXd)

NCT02564900

Modi

2020

Phase I

Heavily pretreated

HER2 low MBC

54

T-DXd

ORR 37.0% (95% CI 24.3–51.3)

DOR 10.4 mo (8.8-NE)

NCT03248492

DESTINY-Breast 01

Modi

2020

Phase II

Heavily pretreated

HER2 + MBC

184

T-DXd

ORR 62.0% (95% CI 54.9–69)

PFS 19.4 mo (14.5–21)

OS 29.1 (24.6–36.1)

NCT03523585

DESTINY-Breast 02

André

2023

Phase III

Third line

HER2 + MBC

608

Arm A: T-DXd

Arm B: physician's choice of capecitabine with lapatinib or trastuzumab

PFS 17.8 vs 6.9 mo,, HR 0.36 (95% CI 0.28–0.45)

OS 39.2 vs 26.5 mo, HR 0.55 (0.50–0.86)

NCT03529110

DESTINY-Breast 03

Cortés

Hurvitz

2022; 2024

2023

Phase III

> First line

HER2 + MBC

524

Arm A: T-DXd

Arm B: T-DM1

PFS 29.0 vs 7.2 mo, HR 0.30 (95% CI 0.24–0.38)

OS 52.6 vs 42.7 mo, HR 0.73 (0.56–0.94)

NCT03734029

DESTINY-Breast 04

Modi

2022

Phase III

> First line

HER2 low MBC

557

Arm A: T-DXd

Arm B: physician's choice of capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel

PFS 9.9 vs 5.1 mo, HR 0.50 (95% CI 0.40–0.63)

OS 23.4 vs 16.8 mo, HR 0.64 (0.49–0.84)

NCT04494425

DESTINY-Breast 06

Curgliano

2024

Phase III

Previously treated

HR+ /HER2 low or ultralow MBC

866

Arm A: T-DXd

Arm B: physician's choice of capecitabine or paclitaxel or nab-paclitaxel

PFS HER2 low 13.2 vs 8.1 mo, HR 0.62 (95% CI 0.51–0.74)

PFS HER2 ultralow 13.2 vs 8.3 mo, HR 0.78 (0.50–1.21)

Overall PFS 13.2 vs 8.1 mo, HR 0.63 (0.53–0.75)

NCT03523572

Hamilton

2021

Phase Ib

Previously treated

Metastatic HER2+ disease that progressed on T-DM1 or HER2 low that progressed on prior treatment

52

Nivolumab + T-DXd

HER2 + cORR 59.4%; DCR 90.6%; PFS 8.6 mo (95% CI 5.4—NE)

HER2 low cORR 37.5%; DCR 75%, PFS 6.3 mo (95% CI 2.3—NE)

AE >  = grade 3 in 43.8%. 5 patients with treatment-related ILD (one grade 5, 4 grade 2)

NCT04132960

DAISY

Mosele

2023

Phase II

Heavily pretreated

HER2+ , HER2 low or HER2 negative MBC

186

T-DXd

ORR HER2 + 70.6% (95% CI 58.3–81)

ORR HER2 low 37.5% (26.4–49.7)

ORR HER2- 29.7% (15.9–47)

NCT04420598

DEBBRAH cohort 5

Vaz Batista

2024

Phase II

Previously treated

HER2+ and HER2 low with leptomeningeal carcinomatosis

41

T-DXd

PFS 8.9 mo (95% CI 2.1-NE)

OS 13.3 mo (2.5-NE)

CBR 71.4%

NCT04752059

TUXEDO

Bartsch

2022

Phase II

Previously treated

HER2+ MBC with CNS metastasis

15

T-DXd

Intracranial ORR 73.3% (95% CI 48.1–89.1)

Datopotamab deruxtecan (Dato-DXd)

NCT03401385

TROPION-PanTumour 01

Bardia

2024

Phase I

Heavily pretreated

a/m HR+ /HER2- or TNBC

85

Dato-DxD

ORR HR + /HER2: 26.8% (95% CI 14.2–42.9)

PFS HR + /HER2- 8.3 mo

ORR TNBC 31.8% (18.6–47.6)

PFS TNBC 4.4 mo

NCT05104866

TROPION-Breast 01

Bardia

2023

Phase III

> First line

HR+ /HER2- MBC

732

Arm A: Dato-DXd

Arm B: physician's choice of capecitabine, eribulin, vinorelbine, or gemcitabine

PFS: 6.9 vs 4.9 mo, HR 0.63 (95% CI 0.52–0.76)

OS immature, HR 0.84 (0.62–1.14)

NCT03742102

BEGONIA Arm 6

Schmid

2023

Phase Ib/II

First line

HR-/HER2 low MBC

46

T-DXd + Durvalumab

ORR 57% (95% CI 41–71); mDOR NE;

mPFS 12.6 mo (8-NE)

NCT03742102

BEGONIA Arm 7

Schmid

2023

Phase Ib/II

First line

a/m TNBC

62

Dato-DXd + Durvalumab

ORR 79% (95% CI 67–88); mDOR 15.5 mo (9.9—NC); mPFS 13.8 mo (11—NC)

NCT01042379

I-SPY2.2

Shatsky

2024

Phase II

Neoadjuvant

Stage II-III HER2- high-risk breast cancer

47

Dato-DXd + Durvalumab

overall pCR 50%

pCR in immune phenotype 79%

pCR in TNBC 62%

NCT05866432

TUXEDO-2

Bartsch

2024

Phase II

Previously treated

TNBC with CNS metastasis

8

Dato-DxD

intracranial response 37.5%

Disatamab vedotin

NCT02881138

NCT03052634

C003 CANCER

Xu

2020

Phase Ib

Previously treated

HER2+ MBC

70

Disatamab vedotin

no DLT

ORR 31.4%

CBR 38.6%

PFS 5.8 months

NCT05331326

Wu

2024

Phase II

Third line

HER2+ and HER2-low MBC with abnormal PAM pathway activation

62

Disatamab vedotin

ORR 34.4%

PFS 3.5 mo (95% CI 2.4–4.6)

Qu

2023

Phase II

Heavily pretreated

HER2+ or HER2 low MBC

120

Disatamab vedotin in combination with ICI, TKI, or chemotherapy

ORR 38.3% (95% CI 30.0–47.3)

PFS 5.7 mo (4.6–6.9)

Enfortumab vedotin

EV-202

NCT04225117

Giordano

2024

Phase II

Heavily pretreated

TNBC or HR+ /HER2- MBC

87

Enfortumab vedotin

TNBC ORR 19%, DCR 57.1%, PFS 3.5 mo (95% CI: 2.1–4.6), OS 12.9 mo (10.3-NE)

HR + /HER2- ORR 15.6%, DCR 51.1%, PFS 5.4 mo (3.4–5.7), OS 19.8 mo (12.8-NE)

Ladiratuzumab vedotin

NCT01969643

SGNLVA-001

Tsai

2021

Phase I

HR + /HER2-: second line

TNBC: third line

LIV + HR + /HER2- and TNBC

81

Ladiratuzumab vedotin

no DLT

ORR TNBC: 28% (95% CI 13–47)

HR + /HER2- pending

NCT03310957

SGNLVA-002

Han

2020

Phase Ib/II

First line

mTNBC

51

Ladiratuzumab vedotin + pembrolizumab

ORR 54% (95% CI: 33.4–73.4)

NCT01042379

I-SPY2

Beckwith

2021

Phase II

Neoadjuvant

Stage II-III HER2- breast cancer

60

Ladiratuzumab vedotin followed by AC

predicted pCR overall: 0.16 (95% CI 0.08–0.24)

Patritumab deruxtecan

NCT02980341

Krop

2023

Phase I/II

Heavily pretreated

MBC

HER3 + 

182

Patritumab deruxtecan

HR + /HER2- ORR 30.1% (95% CI 21.8–39.4), DCR 80.5% (72.0–87.4), mPFS 7.4 mo

TNBC ORR 22.6% (12.3–36.2), DCR 79.2% (65.9–89.2), mPFS 5.5 mo

HER2 + ORR 42.9% (17.7–71.1), DCR 92.9% (66.1–99.8), mPFS 11.0 mo

ICARUS-BREAST-01

NCT04965766

Pistilli

2023

Phase II

> First line

HR + /HER2- MBC

56

Patritumab deruxtecan

3 mo RR 28.6% (95% CI 18.4–41.5), all partial response

SOLTI TOT-HER3

NCT04610528

Oliveira

2023

Phase I

Neoadjuvant/Window of Opportunity

HR + /HER2- or TNBC early breast cancer

37

single dose Patritumab deruxtecan 5.6 mg/kg

ORR 35% in TNBC, 30% in HR + /HER2-

Change in cellularity and TIL associated with ORR (p = 0.049)

No association between HER3 expression and ORR

Sacituzumab tirumotecan

NCT05347134

OptiTROP-Breast01

Xu

2024

Phase III

Second line

a/m TNBC

263

Arm A: Sacituzumab tirumotecan

Arm B: physician's choice of capecitabine, eribulin, gemcitabine or vinorelbine

PFS 5.7 (95% CI: 4.3–7.2) vs 2.3 mo (1.6–2.7)

OS NE (11.2-NE) vs 9.4 (8.5–11.7), HR 0.53 (0.36–0.78)

Trastuzumab duocarmazine (T-Duo)

NCT02277717

Banerji

2019

Phase I

Metastatic

HER2 + or HER2 low MBC

95

T-Duo

HER2 + ORR 33% (95% CI: 20.4–48.4)

HR + /HER2 low ORR 28% (13.8–46.8)

HR-/HER2 low ORR 40% (16.3–67.6)

NCT03262935

TULIP

Saura Manich

Aftimos

2021

2023

Phase III

Previously treated

HER2 + MBC

437

Arm A: T-Duo

Arm B: physician's choice of capecitabine + trastuzumab, eribulin + trastuzumab, vinorelbine + trastuzumab or capecitabine + lapatinib

PFS 7.0 vs 4.9 mo (HR 0.63, p = 0.002)

OS 21.0 vs 19.5 mo, HR 0.87 (95% CI 0.68–1.12)

Selected upcoming clinical trials

NCT05382299

ASCENT-03

Phase III

First line

mTNBC

PD-L1-

540

Arm A: SG

Arm B: physician's choice (paclitaxel, nab-paclitaxel, or gemcitabine)

PFS

NCT05382286

ASCENT-04

Phase III

First Line

mTNBC

PD-L1 + 

440

Arm A: SG + pembrolizumab

Arm B: physician's choice (paclitaxel, nab-paclitaxel, or gemcitabine) + pembrolizumab

PFS

NCT05633654

ASCENT-05/Optimice-RD

Phase III

Adjuvant

Early TNBC with RCB

1514

Arm A: SG + Pembrolizumab

Arm B: Pembrolizumab ± Capecitabine

iDFS

NCT06393374

Phase III

Adjuvant

Early TNBC with RCB

1530

Arm A: SG + Pembrolizumab

Arm B: Pembrolizumab + Capecitabine

iDFS

NCT06393374

Phase II

Neoadjuvant

TNBC

260

Cohort 2: SG + pembrolizumab

pCR

NCT04468061

SACI-IO TNBC

Phase II

First Line

mTNBC

PD-L1-

110

Arm A: SG

Arm B: SG + pembrolizumab

PFS

NCT03971409

InCITe

Phase II

First or second line

mTNBC

150

Arm A: binimetinib followed by binimetinib + avelumab + Liposomal Doxorubicin

Arm B: SG followed by SG + avelumab

Arm C: liposomal doxorubicin followed by liposomal doxorubicin + avelumab

ORR

NCT04595565

SASCIA

Phase III

Residual disease

HR + /HER2- or TNBC

1332

Arm A: SG

Arm B: physician's choice (capecitabine, carboplatin or cisplatin ± pembrolizumab)

iDFS

NCT04448886

Phase II

First or second line

HR + /HER2- MBC

110

Arm A: SG + pembrolizumab

Arm B: SG

PFS

NCT04647916

Phase II

Previously treated

HR + /HER2- or TNBC with CNS metastasis

44

SG

ORR

NCT06263543

SERIES

Phase II

Previously treated

ER + /HER2 low

75

SG

ORR

NCT05143229

ASSET

Phase I

Previously treated

a/m HER2- BC

18

SG + alpelisib

RP2D

NCT05675579

Phase II

Previously treated

early-stage TNBC

25

SG + pembrolizumab

Safety

NCT04039230

Phase I/II

Previously treated

mTNBC

75

SG + talazoparib

DLT

NCT04434040

ASPRIA

Phase II

Residual disease

TNBC

40

Atezolizumab + SG

rate of clearance of cfDNA

NCT03424005

MORPHEUS

Phase Ib/II

First line

a/m breast cancer

Cohort 1: PD-L1 + TNBC

Cohort 2: ICI-naïve TNBC

Cohort 3: HR + /HER2-PIK3CA + 

Cohort 4: HER2 + or HER2low PIK3CA + 

580

Cohort 1 Arm A: Atezolizumab + nab-paclitaxel

Cohort 1 Arm B: Atezolizumab + Nab-Paclitaxel + Tocilizumab

Cohort 1 Arm C: Atezolizumab + SG

Cohort 2 Arm A: Capecitabine

Cohort 2 Arm B: Atezolizumab + Ipatasertib

Cohort 2 Arm C: Atezolizumab + LV

Cohort 2 Arm D: Atezolizumab + Selicrelumab + Bevacizumab

Cohort 2 Arm E: Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)

Cohort 3 Arm A: Inavolisib + Abemaciclib + Fulvestrant

Cohort 3 Arm B: Inavolisib + Ribociclib + Fulvestrant

Cohort 4 Arm A: Inavolisib + Trastuzumab Deruxtecan

Cohort 4 Arm B: Inavolisib + Ribociclib + Letrozole

Cohort 4 Arm C: Inavolisib + Ribociclib + Fulvestrant

Cohort 4 Arm D: Inavolisib + Abemaciclib + Letrozole

Cohort 4 Arm E: Inavolisib + Trastuzumab Deruxtecan

ORR

NCT04873362

ASTEFANIA

Phase III

Adjuvant

Early Breast Cancer with RCB

Any

1700

Arm A: T-DM1 + Atezolizumab

Arm B: T-DM1 + Placebo

iDFS

NCT04740918

KATE3

Phase III

First to third line

Advanced/Metastatic

PD-L1 + 

350

Arm A: T-DM1 + Atezolizumab

Arm B: T-DM1 + Placebo

PFS and OS

NCT04622319

DESTINY-Breast 05

Phase III

First line

Early HER2 + Breast cancer with RCB

1600

Arm A: T-DXd

Arm B: T-DM1

iDFS

NCT04538742

DESTINY-Breast 07

Phase Ib/II

Part 1: Previously Treated

Part 2: First line

HER2 + MBC

245

Arm A: T-DXd

Arm B: T-DXD + durvalumab

Arm C: T-DXd + pertuzumab

Arm D: T-DXd + paclitaxel

Arm E: T-DXd + durvalumab + paclitaxel

Arm F T-DXd + tucatinib

Safety

NCT04556773

DESTINY-Breast 08

Phase I

Part 1: Previously treated

Part 2: First line

HER2 low MBC

138

Arm A: T-DXd + capecitabine

Arm B: T-DXd + durvalumab + paclitaxel

Arm C: T-DXd + capivasertib

Arm D: T-DXd + anastrazole

Arm E: T-DXd + fulvestrant

Safety

NCT04784715

DESTINY-Breast 09

Phase III

First line

HER2 + MBC

1157

Arm A: T-DXd + placebo

Arm B: T-DXd + pertuzumab

Arm C: taxane + pertuzumab + trastuzumab

PFS

NCT05113251

DESTINY-Breast 11

Phase III

First line

Neoadjuvant HER2 + 

927

Arm A: T-DXd

Arm B: T-DXd followed by taxane + pertuzumab + trastuzumab

Arm C: doxorubicin + cyclophosphamide followed by taxane + pertuzumab + trastuzumab

pCR

NCT04739761

DESTINY-Breast 12

Phase III

> First line

HER2 + MBC ± CNS metastasis

506

T-DXd

ORR and PFS

NCT05950945

DESTINY-Breast 15

Phase III

> First line

HER2 low or HER2- MBC

250

T-DXd

Time to Initiation of Subsequent Anticancer Treatement

TRIO-US B-12/TALENT

NCT04553770

Phase II

Neoadjuvant

HR + /HER2 low

88

Arm A: T-DXd

Arm B: T-DXd + anastrazole

pCR

TRANSCENDER

NCT05744375

Phase II

First line

a/m HER2 + with early relapse < 12 mo

41

T-DXd

ORR

NCT03742102

BEGONIA

Phase I/II

First line

mTNBC

243

Arm 1: durvalumab + paclitaxel

Arm 2: capivasertib + durvalumab + paclitaxel

Arm 5: durvalumab + oleclumab + paclitaxel

Arm 6: durvalumab + T-DXd

Arm 7: durvalumab + Dato-DXd

Arm 8: durvalumab + Datopotomab deruxtecan in PD-L1 + 

Safety

NCT05374512

TROPION-Breast 02

Phase III

First line

mTNBC

PD-L1-

637

Arm A: Dato-DXd

Arm B: physician's choice of paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin

PFS

OS

NCT05629585

TROPION-Breast 03

Phase III

Residual disease

adjuvant TNBC

1075

Arm A: Dato-DXd + Durvalumab

Arm B: Dato-DXd

Arm C: physician's choice of capecitabine and/or pembrolizumab

iDFS

NCT06112379

TROPION-Breast-04

Phase III

Neoadjuvant + Adjuvant

Stage II-III TNBC or HR-low, HER2 negative

1728

Arm A: Dato-DXd + Durvalumab → Adjuvant Durvalumab ± Chemotherapy

Arm B: Carboplatin + Paclitaxel + 4xAC/EC + Pembrolizumab → adjuvant Pembrolizumab

pCR and EFS

NCT06103864

TROPION-Breast 05

Phase III

First Line

a/mTNBC

PD-L1 + 

635

Arm A: Dato-DXd + Durvalumab

Arm B: physician's choice of chemotherapy (paclitaxel, nab-paclitaxel, gemcitabine or carboplatin) with pembrolizumab

PFS

NCT06176261

DATO-BASE

Phase III

ER + /HER2-: Prior endocrine therapy

TNBC or HER2-: Any

HER2- MBC with CNS metastasis

58

Dato-DXd

ORR

NCT05460273

TROPION-PanTumour02 Cohort 2

Phase I/II

Third Line

a/mTNBC

78

Dato-DXd

ORR

NCT06508216

COMPASS-TNBC

Phase I/II

First Line

mTNBC with early relapse < 12 mo

60

Arm A: Dato-DXd

Arm B: Dato-DXd + Durvalumab

ORR

NCT06533826

TRADE-DXd

Phase II

First to third line

HER2 low a/MBC

357

Arm A: T-DXd. After progression, then Dato-DXd

Arm B: Dato-DXd. After progression, then T-DXd

ORR

NCT06157892

Phase Ib/II

Second or third line

HER2 + or HER2 low MBC

198

Arm A: Disatamab vedotin

Arm B: Disatamab vedotin + tucatinib

DLT

ORR

NCT05726175

Phase II

Neoadjuvant

stage II-III HER2 low breast cancer

20

Arm A: Disatamab vedotin + penpulimab

pCR

NCT06178159

Phase II

Neoadjuvant

HER2 + breast cancer

80

Arm A: Disatamab vedotin + pertuzumab

Arm B: Disatamab vedotin + pertuzumab + toripalimab

pCR

NCT06227117

Phase II

Neoadjuvant

stage II-III HR-/HER2 + breast cancer

120

Arm A: Disatamab vedotin + toripalimab

Arm B: carboplatin + disatamab vedotin + toripalimab

Arm C: Disitamab Vedotin + toripalimab then EC + toripalimab

pCR

NCT06000033

Phase II

Third line

HR-/HER2 low MBC

35

Disitamab vedotin + anlotinib

ORR

NCT05831878

Phase II

Second line

HR-/HER2 low MBC

36

Disatamab vedotin

ORR

NCT03500380

Phase II/III

Previously treated

HER2 + MBC ± liver metastasis

301

Arm A: Disatamab vedotin

Arm B: capecitabine + lapatinib

PFS

NCT06157892

Rosy

Phase III

Previously treated

HR + /HER2 low MBC

288

Arm A: Disatamab vedotin

Arm B: physician's choice of endocrine therapy

PFS

NCT04400695

Phase III

Second line

HER2 low MBC

366

Arm A: Disatamab vedotin

Arm B:physician's choice of capecitabine, docetaxel, paclitaxel, or vinorelbine

PFS

NCT04300556

Phase I/II

> First line

Solid tumors including mTNBC

142

Farletuzumab ecteribulin

ORR

DLT

Safety

NCT05865990

Phase II

TNBC: > 1st line

HER2+ : > 2nd line

MBC and NSCLC with CNS metastasis

60

Patritumab deruxtecan

Intracranial ORR

OS

NCT04699630

Phase II

TNBC: 2nd line

HER2+ : > 2nd line including T-DXd

MBC

121

Patritumab deruxtecan

ORR

PFS

NCT06298084

ICARUS-BREAST-02

Phase Ib/II

Previously treated, including with T-DXd

MBC

152

Patritumab deruxtecan + olaparib

Safety, ORR, DOR, PFS, CBR

NCT05569811

VALENTINE

Phase II

Neoadjuvant

HR + /HER2-; Ki67 > 20% and/or high genomic risk

120

Arm A: chemotherapy

Arm B: Patritumab deruxtecan + letrozole

Arm C: Patritumab deruxtecan

pCR

NCT06312176

TroFuse-010

Phase III

Previously treated

HR + /HER2- MBC

1200

Arm A: Sacituzumab tirumotecan

Arm B: Sacituzumab tirumotecan + pembrolizumab

Arm C: physician's choice of capecitabine, liposomal doxorubicin, paclitaxel, or nab-paclitaxel

PFS

NCT06393374

Phase III

Adjuvant

Early TNBC with RCB

1530

Arm A: Sacituzumab tirumotecan + pembrolizumab

Arm B: physician's choice of capecitabine or capecitabine + pembrolizumab

iDFS

NCT06312176

Phase III

Previously treated

Advanced or Metastatic

1200

1200

Arm A: Sacituzumab Tirumotecan

Arm B: Sacituzumab Tirumotecan + Pembrolizumab

Arm C: Treated of Physician's Choice

PFS

NCT01042379

I-SPY2

Phase II

Neoadjuvant

Stage II-III HER2- breast cancer

T-Duo

predicted pCR