Trastuzumab deruxtecan (T-DXd)

DRUG8 trials

Sponsors

Daiichi Sankyo, AstraZeneca, GI Innovation, Inc., Danish Breast Cancer Cooperative Group, Fudan University

Conditions

Advanced Solid MalignanciesAdvanced Solid TumorBasal LikeBreast CancerBreast Cancer With Brain MetastasisColorectal Cancer (CRC)Cutaneous MelanomaER-positive Breast Cancer

Phase 1

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

RecruitingNCT05417594

AstraZenecaAdvanced Solid Malignancies

Start: 2022-06-24End: 2027-08-11Target: 695Updated: 2026-03-12

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

RecruitingNCT05824975

GI Innovation, Inc.Advanced Solid Tumor, Colorectal Cancer (CRC), Cutaneous Melanoma +6

Start: 2023-05-30End: 2027-04-24Target: 358Updated: 2024-11-25

Phase 2

Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer

Not yet recruitingNCT06797622

Fudan UniversityBreast Cancer, Metastatic Breast Cancer

Start: 2025-02-15End: 2027-04-15Target: 50Updated: 2025-01-28

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

RecruitingNCT07069712

AstraZenecaGastroesophageal Adenocarcinoma

Start: 2025-07-17End: 2028-09-06Target: 100Updated: 2026-03-10

T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis

Not yet recruitingNCT07150208

Fudan UniversityBreast Cancer With Brain Metastasis, HER2-low Expressing Breast Cancer

Start: 2025-09-30End: 2028-09-30Target: 140Updated: 2025-09-02

Phase 3

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

Active, not recruitingNCT03529110

Daiichi SankyoBreast Cancer

Start: 2018-08-09End: 2026-07-30Updated: 2025-10-21

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

WithdrawnNCT06585969

Danish Breast Cancer Cooperative GroupBasal Like, ER-positive Breast Cancer, Her2 Enriched +2

Start: 2026-01-01End: 2026-01-01Updated: 2026-02-12

Unknown Phase

Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

RecruitingNCT06846996

Daiichi SankyoHER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction

Start: 2025-02-27End: 2027-07-31Target: 260Updated: 2025-07-08

Related Papers

Abstract PS5-01-30: Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (mBC): Final analysis from DESTINY-Breast03

Clinical Cancer Research2026-02-17

GEMINI-Perioperative (PeriOp) Gastric: A phase 2 study of novel agent-based combinations as PeriOp therapy for previously untreated, locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma.

Journal of Clinical Oncology2026-01-10

Trial in progress: A Phase 2a Study of GI-102 (CD80/IL2v3) as a consolidation therapy in patients with relapsed/refractory diffuse large B-cell lymphoma following anti-CD19 chimeric antigen receptor T-cell therapy (CARNATION trial)

Blood2025-11-03

Abstract PS8-03: Exploratory biomarker analysis of Trastuzumab deruxtecan (T-DXd) vs Trastuzumab emtansine (T-DM1) efficacy in human epidermal growth factor receptor 2–positive (HER2+) metastatic breast cancer (mBC) in DESTINY-Breast03 (DB-03)

Clinical Cancer Research2025-06-132 citations

Phase II study evaluating 68Ga-FAPI PET uptake heterogeneity as a predictor of T-DXd treatment response in HER2-positive breast cancer brain metastases.

Journal of Clinical Oncology2025-05-28

Trastuzumab deruxtecan versus trastuzumab emtansine in Asian patients with HER2‐positive metastatic breast cancer

Cancer Science2024-07-0917 citations

Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial.

2024-06-0282 citations

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with HER2+ metastatic breast cancer (mBC): Updated survival results of DESTINY-Breast03.

Journal of Clinical Oncology2024-06-0111 citations

Pooled analysis on characteristics of nausea and vomiting in patients receiving trastuzumab deruxtecan (T-DXd) in clinical studies.

Journal of Clinical Oncology2024-06-017 citations

Pooled analysis by best confirmed response to trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ metastatic breast cancer (mBC) from DESTINY-Breast-01, -02, and -03.

Journal of Clinical Oncology2024-06-013 citations

A first-in-human, phase 1/2a study of GI-102 (CD80-IL2v3) in patients with advanced or metastatic solid tumors: Initial results from dose escalation.

Journal of Clinical Oncology2024-06-011 citations

Efficacy and safety of trastuzumab deruxtecan in treating human epidermal growth factor receptor 2-low/positive advanced breast cancer:A meta-analysis of randomized controlled trials.

2024-03-0310 citations

Trastuzumab Deruxtecan Versus Trastuzumab Emtansine for Breast Cancer: A Plain Language Summary of the DESTINY-Breast03 Study

Future Oncology2023-12-071 citations

Pertuzumab plus high-dose trastuzumab for HER2-positive breast cancer with brain metastases: PATRICIA final efficacy data

npj Breast Cancer2023-11-1716 citations

Preclinical Characterization of AZD9574, a Blood–Brain Barrier Penetrant Inhibitor of PARP1

Clinical Cancer Research2023-11-1549 citations

729 A first-in-human, open-label, multicenter, phase 1/2a, dose escalation and expansion study of GI-102, a novel immunocytokine combining CD80-IL2v3, in patients with advanced or metastatic solid tumors

Regular and Young Investigator Award Abstracts2023-10-31

An age-specific pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and -03.

Journal of Clinical Oncology2023-06-0110 citations

Real-World Perspectives and Practices for Pneumonitis/Interstitial Lung Disease Associated With Trastuzumab Deruxtecan Use in Human Epidermal Growth Factor Receptor 2-Expressing Metastatic Breast Cancer.

2023-05-1949 citations

SA 6.1 Patient selection, dose and fractionation for external beam radiotherapy in patients with early breast cancer

The Breast2023-03-14

Abstract GS2-01: GS2-01 Trastuzumab deruxtecan vs physician’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized, phase 3 study DESTINY-Breast02

Cancer Research2023-03-0121 citations

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