Clinical trials: Breast Cancer Patients Treated With T-DXd
HER2-positive Breast Cancer
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and…
- Trial name
- NCT06833268
- Testing
- No drug
- Where
- United States
- Volunteers
- 228 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer
GRADE is trying to find out if there is a link between a hormone called GDF-15 and the side effects that people can experience when taking T-DXd. GDF-15 can be measured in the blood.
- Trial name
- GRADE (NCT07465172)
- Testing
- Blood collection for GDF-15
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 150 people
- Sponsor
- Breast Cancer Trials, Australia and New Zealand
Breast Cancer, Estrogen Receptor-Positive, HER2 Low Breast Cancer
A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer
This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary…
- Trial name
- NCT06733233
- Testing
- T-DXd combined with immune checkpoint inhibitor
- Volunteers
- 23 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.
- Trial name
- DPT02 (NCT04482309)
- Testing
- Trastuzumab deruxtecan
- Where
- 89 sites in United States, Australia and 15 more
- Volunteers
- 477 people
- Sponsor
- AstraZeneca
Breast Cancer
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
- Trial name
- NCT06578286
- Testing
- ARX788
- Volunteers
- 44 people
- Sponsor
- Fudan University
Advanced Breast Cancer
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer
This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive…
- Trial name
- NCT07630103
- Testing
- Trastuzumab Rezetecan for Injection (SHR-A1811), Trastuzumab Deruxtecan for Injection (T-DXd)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd, Patients With HER2-low Advanced Breast Cancer Treated With T-DXd
NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with…
- Trial name
- PRO-NEPA (NCT07132749)
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yeon Hee Park
Breast Cancer
A Phase II Study of Trastuzumab Deruxtecan (T-DXd) Plus Pyrotinib in HER2-Positive Advanced Breast Cancer After Progression on T-DXd
This is a single-arm, exploratory, phase II study evaluating the efficacy and safety of trastuzumab deruxtecan (T-DXd) in combination with pyrotinib in patients with HER2-positive advanced breast cancer whose disease has…
- Trial name
- NCT07836257
- Testing
- Trastuzumab Deruxtecan (T-DXd), Pyrotinib
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Fujian Medical University
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Breast Cancer, HER2-low Breast Cancer
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab…
- Conditions
- Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TRADE DXd (NCT06533826)
- Testing
- Trastuzumab Deruxtecan, Datopotamab Deruxtecan
- Where
- 11 sites in United States
- Volunteers
- 357 people
- Sponsor
- Ana C Garrido-Castro, MD
Locally Advanced or Metastatic Breast Cancers
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer…
- Trial name
- TDXdose (NCT07195344)
- Testing
- Pharmacokinetics blood samples
- Where
- 10 sites in France
- Volunteers
- 210 people
- Sponsor
- Institut Claudius Regaud
Triple-Negative Breast Cancer
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype…
- Trial name
- NCT05953168
- Testing
- Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Fudan University
Breast Cancer
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles.
- Trial name
- NCT07416253
- Testing
- Trastuzumab rezetecan, Trastuzumab deruxtecan
- Volunteers
- 68 people
- Sponsor
- Henan Cancer Hospital
HER2 Positive Metastatic Breast Cancer
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
- Trial name
- NCT04829604
- Testing
- ARX788
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 72 people
- Sponsor
- Ambrx, Inc.
Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer
Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer
This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of…
- Trial name
- MEGA-TACT-BC3 (NCT07543536)
- Testing
- Megestrol Acetate + Trastuzumab Deruxtecan
- Where
- 2 sites in China
- Volunteers
- 132 people
- Sponsor
- Sun Yat-sen University
Breast Cancer, Metastatic Breast Cancer
Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer
The purpose of this study was to explore the predictive value of the heterogeneity of 68Ga-FAPI PET-CT uptake before treatment on the response of T-DXd treatment in patients with brain metastases of HER2-positive breast cancer.
- Trial name
- NCT06797622
- Testing
- Trastuzumab deruxtecan (T-DXd)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Fudan University
HER2 Overexpression, Advanced Stage Breast Cancer
A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in…
- Conditions
- HER2 Overexpression, Advanced Stage Breast Cancer, Low Expression of HER2
- Trial name
- NCT07035353
- Testing
- T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.
- Volunteers
- 200 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
HER2-positive Breast Cancer
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment.
- Trial name
- EUROPA T-DXd (NCT05458401)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in Ireland, Italy and 1 more
- Volunteers
- 256 people
- Sponsor
- Daiichi Sankyo
Breast Cancer Metastatic, Breast Cancer Stage IV
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the…
- Trial name
- SAFIR3LibHERty (NCT06680596)
- Testing
- trastuzumab derxutecan
- Where
- 40 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or…
- Trial name
- NCT06271837
- Testing
- Trastuzumab deruxtecan, Bevacizumab
- Where
- 29 sites in China
- Volunteers
- 127 people
- Sponsor
- AstraZeneca