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NCT03529110 · ClinicalTrials.gov registry record · 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]
A Phase 3 study of Breast Cancer, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 3
- Development phase
- 524
- Enrollment target
- 20
- Study locations
NCT03529110: Active Phase 3 study of Breast Cancer, sponsored by Daiichi Sankyo.
NCT03529110 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 524 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03529110, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Daiichi Sankyo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 524 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Primary Outcome
Progression-free survival (PFS) by BICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Conditions Studied
Interventions
- DRUG Trastuzumab deruxtecan (T-DXd)
- DRUG Ado-trastuzumab emtansine (T-DM1)
Study Locations (20)
California
- UCLA Hematology Oncology - Los Angeles
- Sharp Memorial Hospital - San Diego
- University of California San Francisco - San Francisco
- Innovative Clinical Research Institute - Whittier
Ohio
- University of Cincinnati Medical Center - Cincinnati
- Seidman Cancer Center - Cleveland
- The Ohio State University - Columbus
- Dayton Physicians, LLC - Kettering
Florida
- Florida Cancer Specialists-Broadway - Fort Myers
- Florida Cancer Specialists NORTH - St. Petersburg
New York
- North Shore Hematology Oncology Associates, PC - East Setauket
- University of Rochester - Rochester
District of Columbia
- Washington Cancer Institute - Washington D.C.
Georgia
- Piedmont Cancer Institute, PC - Atlanta
Illinois
- Loyola University Health System - Maywood
Kentucky
- Norton Cancer Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 3 |
What the registry record for NCT03529110 still lists
NCT03529110 is an interventional study that assigns participants to a tested intervention. The registered 524 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab deruxtecan (T-DXd) is the first listed.
NCT03529110 names 20 study sites across 12 states, led by California, Ohio, Florida.
Frequently Asked Questions
What is clinical trial NCT03529110 about?
NCT03529110 is a clinical study titled "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]". This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
What is the current status of trial NCT03529110?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 524 participants. The study started on 2018-08-09. Estimated completion is 2026-07-30.
What conditions does trial NCT03529110 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03529110?
The interventions under investigation include: Trastuzumab deruxtecan (T-DXd) (DRUG), Ado-trastuzumab emtansine (T-DM1) (DRUG).
Who is sponsoring clinical trial NCT03529110?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03529110 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03529110's enrollment target sits among peer trials
524 188th of 1224 higher than 1,037 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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