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NCT05950945

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

Recruiting now Phase 3 Last updated 8 April 2026
What this trial tests

Phase 3 trial testing Trastuzumab Deruxtecan in Breast Cancer in 250 participants. Currently enrolling.

Timeline
30 December 2023
Primary endpoint
1 October 2027
1 October 2027

Quick facts

Lead sponsorDaiichi Sankyo
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment250
Start date30 December 2023
Primary completion1 October 2027
Estimated completion1 October 2027
Sites86 locations across Italy, Netherlands, Belgium, Ireland, Portugal, Australia, China, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Daiichi Sankyo — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current and future immunotherapy for breast cancer.
    Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
  2. Mechanisms of action and resistance to anti-HER2 antibody-drug conjugates in breast cancer.
    Saleh K, Khoury R, Khalife N, Chahine C, et al · · 2024 · cited 27× · PMID 39050884 · DOI 10.20517/cdr.2024.06
  3. Toxicities and management strategies of emerging antibody-drug conjugates in breast cancer.
    Kang S, Kim SB. · · 2025 · cited 15× · PMID 40151551 · DOI 10.1177/17588359251324889
  4. HER2-Low Breast Cancer: Now and in the Future.
    Kang S, Kim SB. · · 2024 · cited 15× · PMID 38291745 · DOI 10.4143/crt.2023.1138
  5. Outcomes with trastuzumab deruxtecan by biomarker status, line of treatment and prior receipt of sacituzumab govitecan in a large real-world database of patients with metastatic breast cancer.
    Tarantino P, Lee D, Foldi J, Soulos PR, et al · · 2025 · cited 13× · PMID 40532362 · DOI 10.1016/j.esmoop.2025.105330
  6. Advancements in antibody-drug conjugates as cancer therapeutics.
    Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
  7. Future AI Will Most Likely Predict Antibody-Drug Conjugate Response in Oncology: A Review and Expert Opinion.
    Sobhani N, D'Angelo A, Pittacolo M, Mondani G, et al · · 2024 · cited 10× · PMID 39272947 · DOI 10.3390/cancers16173089
  8. Advances in the study of marketed antibody-drug Conjugates (ADCs) for the treatment of breast cancer.
    Liang Y, Zhang P, Li F, Lai H, et al · · 2023 · cited 10× · PMID 38352694 · DOI 10.3389/fphar.2023.1332539

Verify or expand the search:

Other trials of Trastuzumab Deruxtecan

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Daiichi Sankyo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05950945.

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