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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