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. 2021 Jul 2;6(4):100204. doi: 10.1016/j.esmoop.2021.100204

Table 4.

Ongoing clinical trials with trastuzumab deruxtecan for patients with breast cancer

Trial Phase Treatment setting Breast cancer subtype Patient population Design Experimental arm Control arm Sample size NCT number Recruitment status (locations)
Unresectable locally advanced/metastatic setting
DESTINY-Breast12 IV Advanced HER2+ After trastuzumab, pertuzumab or T-DM1; ≤2 prior regimens for metastatic disease Single arm T-DXd NA 500 NCT04739761 Not yet recruiting
DESTINY-Breast09 III Advanced HER2+ First-line advanced setting Open-label, three-arm RCT Arm A: T-DXd with placebo
Arm B: T-DXd with pertuzumab		 Taxane + pertuzumab + trastuzumab 1134 NCT04784715 Not yet recruiting
DESTINY-Breast02 III Advanced HER2+ After prior T-DM1 Open-label RCT T-DXd Capecitabine + trastuzumab or capecitabine + lapatinib 600 NCT03523585 Recruitment closed
DESTINY-Breast03 III Advanced HER2+ After prior trastuzumab and taxane Open-label RCT T-DXd T-DM1 500 NCT03529110 Recruitment closed
DESTINY-Breast06 III Advanced HER2-low/HR+ After progression on prior endocrine treatment(s), no prior chemotherapy for advanced disease Open-label RCT T-DXd Capecitabine, paclitaxel or nab-paclitaxel 850 NCT04494425 Recruiting (across 25 countries worldwide)
DESTINY-Breast04 III Advanced HER2-low After 1-2 lines of prior chemotherapy for metastatic disease Open-label RCT T-DXd Capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel 557 NCT03734029 Recruitment closed
DAISY II Advanced HER2+
HER2-low
HER2 IHC0		 After progression on standard treatment Single arm, multicohort T-DXd NA 162 NCT04132960 Recruitment closed
HER2CLIMB-04 II Advanced HER2+ After ≥2 prior anti-HER2 regimens for metastatic disease Single arm T-DXd + tucatinib NA 70 NCT04539938 Recruiting (United States)
DEBBRAH II Brain metastases HER2+
HER2-low		 Untreated or treated brain or leptomeningeal metastases, after standard treatment Single arm, multicohort T-DXd NA 39 NCT04420598 Recruiting (Spain)
Not yet (Portugal)
TUXEDO-1 II Brain metastases HER2+ Untreated or treated brain metastases, after trastuzumab and pertuzumab ± T-DM1 Single arm T-DXd NA 15 NCT04752059 Recruiting (Austria)
DESTINY-Breast07 Ib/II Advanced HER2+ Dose-finding phases: in second line or later
Dose-expansion phases: first-line advanced setting
Two modules for patients with active brain metastases		 Modular dose finding and expansion T-DXd single agent or with
  • -

    durvalumab

  • -

    pertuzumab

  • -

    paclitaxel

  • -

    durvalumab and paclitaxel

  • -

    tucatinib

 NA 450 NCT04538742 Recruiting (across 15 countries worldwide)
BEGONIA Ib/II Metastatic HER2-low/HR− First-line treatment Open-label, multi-arm Arm 6: T-DXd + durvalumab NA 57 (arm 6) NCT03742102 Recruiting (United States, Canada, Korea, Poland, Taiwan, UK)
DESTINY-Breast08 Ib Advanced HER2-low/HR+ Dose-finding phases: in second line or later
Dose-expansion phases: first- or second-line advanced setting		 Modular dose finding and expansion T-DXd +
  • -

    capecitabine

  • -

    durvalumab and paclitaxel

  • -

    capivasertib

  • -

    anastrozole

  • -

    fulvestrant

 NA 185 NCT04556773 Recruiting (United States, Australia, Korea, Taiwan, Canada)
DS8201-A-U106 Ib Advanced HER2+
HER2-low		 Disease progression after standard treatment, including T-DM1 for HER2+ Dose finding and expansion T-DXd + pembrolizumab NA 115 NCT04042701 Recruiting (United States, France)
DS8201-A-U105 Ib Advanced HER2+
HER2-low		 Disease progression after standard treatment, including T-DM1 for HER2+ Dose finding and expansion T-DXd + nivolumab NA 99 NCT03523572 Recruitment closed
DASH trial I/Ib Advanced HER2+
HER2-low		 Disease progression after ≥1 prior chemotherapy, including 1 anti-HER2 regimen Dose finding and expansiona T-DXd + ceralasertib NA 15 NCT04704661 Not yet recruiting
DS8201-A-J102 I Advanced HER2+
HER2-low		 Disease progression after standard treatment Single-arm, safety study (QT interval, PK, AE) T-DXd NA 51 NCT03366428 Recruitment closed
DS8201-A-A104 I Advanced HER2+
HER2-low		 Disease progression after ≥1 prior chemotherapy Single-sequence, crossover safety study (DDI, AE) T-DXd + ritonavir or itraconazole NA 40 NCT03383692 Recruitment closed
NCI-2020-01206 I Advanced HER2+
HER2-low		 Disease progression after standard treatment Single-arm, safety study (PD, AE) T-DXd NA 28 NCT04294628 Recruiting (United States)
DS8201-A-A103 I Advanced HER2+
HER2-low		 Disease progression after standard treatment Single-arm, safety study (AE, PK) T-DXd NA 12 NCT03368196 Recruitment closed
Early/curative setting
DESTINY-Breast05 III Post-neoadjuvant HER2+ Residual disease after neoadjuvant chemotherapy and HER2-directed treatment Open-label RCT T-DXd T-DM1 1600 NCT04622319 Recruiting (across 31 countries worldwide)
20-001275 II Early or locally advanced HER2-low/HR+ Neoadjuvant setting, previously untreated Open-label RCT T-DXd + anastrozole T-DXd 88 NCT04553770 Recruiting (United States)
Translational/non-interventional studies
HER2-PREDICT — Advanced HER2+
HER2-low		 Patients treated with T-DXd in a clinical trial Non-interventional translational Tumor and blood sample collection NA 180 NCT04257162 Recruiting (Spain)

Source: ClinicalTrials.gov: March 2021.

AE, adverse events; BM, brain metastases; DDI, drug–drug interactions; HER2, human epidermal growth factor receptor-2; HR, hormone receptor; IHC, immunohistochemistry; LMC, leptomeningeal carcinomatosis; NA, not applicable; NCT, National Clinical Trial; RCT, randomized, controlled trial; T-DM1, ado-trastuzumab emtansine; PD, pharmacodynamics; PK, pharmacokinetics; SG, sacituzumab govitecan-hziy; T-DXd, trastuzumab deruxtecan; TNBC, triple-negative breast cancer; TPC, treatment of physician's choice.

a

Expansion cohorts only enroll gastroesophageal and colorectal cancer.