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NCT03734029 · ClinicalTrials.gov registry record · Phase 3
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
A Phase 3 study of Breast Cancer, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 3
- Development phase
- 557
- Enrollment target
- 20
- Study locations
NCT03734029: Active Phase 3 study of Breast Cancer, sponsored by Daiichi Sankyo.
NCT03734029 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 557 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03734029, 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
- 557 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body
Primary Outcome
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confid
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Eribulin
- DRUG Trastuzumab deruxtecan (DS-8201a)
Study Locations (20)
Florida
- Sylvester Comprehensive Cancer Center - Deerfield Beach - Boca Raton
- Florida Cancer Specialists (South Region) - Fort Myers
- Memorial Healthcare System MRH Cancer Center - Hollywood
- Orlando Health, Inc. - Orlando
- Moffitt Cancer Center -Tampa - Tampa
California
- UCLA School of Medicine - Los Angeles
- Stanford Cancer Institute - Palo Alto
- Cancer Care Associates Medical Group, Inc. TORI - Redondo Beach
- University of California at San Francisco (PARENT) - San Francisco
Arizona
- Ironwood Cancer & Research Centers - Chandler II - Chandler
- Banner MD Anderson Cancer Center - Gilbert
- Cancer Treatment Centers of America at Western Regional Medical Center - Goodyear
Illinois
- University of Chicago Medical Center - Chicago
- Cancer Treatment Centers of America - Zion
Connecticut
- Eastern Connecticut Hematology/Oncology Assoc. - Norwich
Delaware
- Christiana Care Health Services, Inc. - Newark
Georgia
- Cancer Treatment Centers of America-Georgia - Newnan
Kansas
- Cancer Center of Kansas - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 557 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2026-08-01 |
| Phase | Phase 3 |
What the registry record for NCT03734029 still lists
NCT03734029 is an interventional study that assigns participants to a tested intervention. The registered 557 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 (80% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT03734029 names 20 study sites across 10 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03734029 about?
NCT03734029 is a clinical study titled "Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]". This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body
What is the current status of trial NCT03734029?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2018-12-27. Estimated completion is 2026-08-01.
What conditions does trial NCT03734029 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03734029?
The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Trastuzumab deruxtecan (DS-8201a) (DRUG).
Who is sponsoring clinical trial NCT03734029?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03734029 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, Florida. 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 NCT03734029's enrollment target sits among peer trials
557 182nd of 1224 higher than 1,043 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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