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NCT03523585 · ClinicalTrials.gov registry record · Phase 3
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT03523585: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT03523585 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 608 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523585, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body
Primary Outcome
Progression-free survival (PFS) by BICR was defined as the time from the date of randomization 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.
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Trastuzumab deruxtecan
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2025-12-23 |
| Phase | Phase 3 |
What the finished NCT03523585 record still lists
NCT03523585 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT03523585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03523585 about?
NCT03523585 is a clinical study titled "DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]". This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body
What is the current status of trial NCT03523585?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2018-08-01. Estimated completion is 2025-12-23.
What interventions are being tested in trial NCT03523585?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Trastuzumab deruxtecan (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT03523585?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03523585's enrollment target sits among peer trials
608 603rd of 2000 higher than 1,396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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