Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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]
NCT03529110 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03529110
The ClinicalTrials.gov registry entry for NCT03529110 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 524 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03529110 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Ohio, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03529110?
The interventions under investigation include: Trastuzumab deruxtecan (T-DXd) (DRUG), Ado-trastuzumab emtansine (T-DM1) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03529110?
This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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