Clinical Trials Logo

Clinical Trial Summary

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate. The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).


Clinical Trial Description

The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8 months. The screening period is 28 days and each cycle of treatment is 21 days. The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03368196
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 1
Start date April 2, 2018
Completion date September 28, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05851053 - Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
Recruiting NCT05507034 - Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment.
Recruiting NCT03715686 - To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes N/A
Recruiting NCT06337214 - TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy N/A
Recruiting NCT05033769 - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer Phase 4
Recruiting NCT05512260 - Development, Implementation and Evaluation of an Individual Decision Aid in Swedish Cancer Screening Programs N/A
Recruiting NCT05392608 - SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) Phase 2
Active, not recruiting NCT03678883 - 9-ING-41 in Patients With Advanced Cancers Phase 2
Not yet recruiting NCT06251544 - TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer Phase 1
Recruiting NCT04109079 - Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy N/A
Not yet recruiting NCT05465031 - Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM) Phase 4
Completed NCT04678544 - Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients N/A
Recruiting NCT03756064 - Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer N/A