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NCT04622319 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
A Phase 3 study of HER2-Positive Primary Breast Cancer and Residual Invasive Breast Cancer, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 3
- Development phase
- 1,600
- Enrollment target
- 20
- Study locations
NCT04622319 is a Phase 3 study of HER2-Positive Primary Breast Cancer and Residual Invasive Breast Cancer that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 1,600 participants. The trial reports 20 study locations across 2 states.
The verdict
NCT04622319, a Phase 3 study of HER2-Positive Primary Breast Cancer and Residual Invasive Breast Cancer, is active but no longer recruiting, sponsored by Daiichi Sankyo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,600 participants
- Enrollment target
- 20
- Study locations
Study Summary
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
Conditions Studied
Interventions
- DRUG T-DM1
- DRUG DS-8201a
Study Locations (20)
California
- The Oncology Institute of Hope & Innovation - Anaheim
- Kaiser Permanente - Anaheim
- Kaiser Permanente - Baldwin Park
- Kaiser Permanente - Bellflower
- Kaiser Permanente - Fontana
- Orange Coast Blood and Cancer Care - Fountain Valley
- Kaiser Permanente - Harbor City
- Kaiser Permanente - Irvine
- Long Beach Memorial TCI - Long Beach
- Kaiser Permanente - Los Angeles
- Kaiser Permanente - Ontario
- Kaiser Permanente - Panorama City
- Kaiser Permanente - Riverside
- Kaiser Permanente - San Diego
- Kaiser Permanente - San Marcos
- Kaiser Permanente - West Los Angeles
- Kaiser Permanente - Woodland Hills
Florida
- SCRI FCS North- Altamonte - Altamonte Springs
- SCRI FCS South- Bonita - Bonita Springs
- SCRI FCS North- Brandon Cancer Center - Brandon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04622319
The ClinicalTrials.gov registry entry for NCT04622319 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HER2-Positive Primary Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which T-DM1 is the first listed.
NCT04622319 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.
Frequently Asked Questions
What is clinical trial NCT04622319 about?
NCT04622319 is a clinical study titled "A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)". Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of tras...
What is the current status of trial NCT04622319?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,600 participants. The study started on 2020-12-04. Estimated completion is 2030-12-31.
What conditions does trial NCT04622319 study?
This clinical trial studies the following conditions: HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer.
What interventions are being tested in trial NCT04622319?
The interventions under investigation include: T-DM1 (DRUG), DS-8201a (DRUG).
Who is sponsoring clinical trial NCT04622319?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04622319 being conducted?
This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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HER2-Positive Primary Breast Cancer
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