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NCT03262935 · ClinicalTrials.gov registry record · Phase 3
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
A Phase 3 study, sponsored by Byondis B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 437
- Enrollment target
NCT03262935: Completed Phase 3 study, sponsored by Byondis B.V..
NCT03262935 is a Phase 3 study that has completed, run by Byondis B.V.. The registered enrollment target is 437 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03262935, a Phase 3 study, has completed, sponsored by Byondis B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 437 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.
Primary Outcome
Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.
Interventions
- DRUG (vic-)trastuzumab duocarmazine
- DRUG Physician's choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 3 |
What the finished NCT03262935 record still lists
NCT03262935 is an interventional study that assigns participants to a tested intervention. The registered 437 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 (43% lower).
The record links to 0 conditions, and to 2 interventions - of which (vic-)trastuzumab duocarmazine is the first listed.
NCT03262935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03262935 about?
NCT03262935 is a clinical study titled "SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer". The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.
What is the current status of trial NCT03262935?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 437 participants. The study started on 2017-12-15. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03262935?
The interventions under investigation include: (vic-)trastuzumab duocarmazine (DRUG), Physician's choice (DRUG).
Who is sponsoring clinical trial NCT03262935?
This trial is sponsored by Byondis B.V., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03262935's enrollment target sits among peer trials
437 874th of 2000 higher than 1,127 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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