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Table 1 Ongoing clinical trials with T-Dxd including breast cancer patients

From: Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions

NCT identifier

Trial name

Phase

Experimental arm

Control arm

Setting

Population

Primary endpoint

NCT03523585

DESTINY-Breast02

III

T-DXd

Investigator’s choice

Prior T-DM1

HER2+ MBC

PFS

NCT03529110

DESTINY-Breast03

III

T-DXd

T-DM1

Prior taxane +trastuzumab

HER2+ MBC

PFS

NCT03734029

DESTINY-Breast04

III

T-DXd

Investigator’s choice

1 or 2 prior chemotherapies.

POD on ET if HR+

HER2-low MBC

PFS

NCT04132960

DAISY

II

T-DXd

-

≥ 2nd line

MBC

C1: HER2 over-expressing

C2: HER2 low expressing

C3: non expressing d

BOR

NCT04752059

TUXEDO-1

II

T-DXd

-

≥ 2nd line

Newly diagnosed or progressing BM

HER2+MBC

CNS ORR

NCT04784715

DESTINY-Breast09

III

T-DXd+/− P

THP

1st line

No prior chemo or POD ≤ 6 mo from adj therapy HER2+ MBC

PFS

NCT04622319

DESTINY-Breast05

III

T-DXd

T-DM1

Post-neoadjuvant

Primary BC with residual invasive disease

IDFS

NCT04420598

DEBBRAH

II

T-DXd

-

≥ 2nd line

BM or LMD in HER2+or HER2-low MBC

CNS ORR, 16w PFS and OS of T-DXd

NCT04494425

DESTINY-Breast06

III

T-DXd

treatment of Investigator’s Choice

≥ 3rd line

HR+ HER2-low MBC

PFS

NCT04257162

HER2-PREDICT

-

T-DXd

-

-

Patients treated with T-DXd+

ERBB2 mRNA cut-point predictive of T-DXd response

NCT04042701

-

Ib/II

T-DXd+ pembrolizumab

-

≥ 2nd line

HER2+ or low MBC and HER2+ or mut NSCLC

DLT and ORR

NCT04553770

-

II

T-DXd+/− ANA

-

Neoadjuvant setting

HR+ HER2-low

EBC

pCR rate

NCT04556773

DESTINY-Breast 08

Ib

T-DXd+

Durva or T or Capi or ANA or Fulv or Cape

-

≥ 2nd line

HER2-low MBC

Safety

NCT04294628

-

I

T-DXd

-

≥ 2nd line

Any advanced solid tumor, HER2+

Effect of T-DXd on Top1cc

NCT04539938

HER2CLIMB-04

II

T-DXd+ tucatinib

-

≥ 2nd line

HER2+MBC

ORR

NCT04704661

DASH

I/Ib

T-DXd and AZD6738a

-

≥ 2nd line

HER2+/low/ mutant solid tumors

DLT and RP2D

NCT03742102

BEGONIA

Ib/II

Durvalumab + T-DXd or Capi or Oleb or T or DS-1062c

-

1st line

TNBC

Safety and ORR

  1. Abbreviations: MBC metastatic breast cancer, EBC early breast cancer, PFS progression-free survival, BOR best objective response rate, C cohort, mo months, BM brain metastases, P pertuzumab, THP taxane, trastuzumab, and pertuzumab, IDFS invasive disease-free survival, CNS central nervous system, ORR overall response rate, OS overall survival, DLT dose-limiting toxicities, mut mutant NSCLC, non-small cell lung cancer, pCR pathological complete response, ANA anastrozole, Durva durvalumab, T paclitaxel, Capi capivarsetib, Fulv fulvestrant, Cape capecitabine, Top1cc topoisomerase 1 cleavable complex, RP2D recommended phase 2 dose, Ole oleclumab, C cohort, LMD leptomeningeal disease
  2. aAZD6738: ATR inhibitor
  3. bOleclumab: anti-CD73 Ab
  4. cADC anti-TROP2
  5. dHER2 over-expressing: HER2 IHC3+ or HER2 IHC2+/ISH+; HER2 low-expressing IHC1+ or IHC2+/ISH−; HER2 non-expressing IHC0
  6. Note: https://clinicaltrials.gov/ April 2021