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NCT05950945 · ClinicalTrials.gov registry record · Phase 3
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT05950945: Recruiting Phase 3 study of Breast Cancer, sponsored by Daiichi Sankyo.
NCT05950945 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 250 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05950945, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.
Primary Outcome
TTNT is defined as the time interval from the date of first dose of T-DXd to the initiation of the next anticancer treatment or death due to any cause.
Conditions Studied
Interventions
- DRUG Trastuzumab Deruxtecan
Study Locations (20)
Other
- GenesisCare St Andrews Hospital - Adelaide
- Fiona Stanley Hospital - Murdoch
- Institut Jules Bordet - Anderlecht
- GZA Ziekenhuizen - Antwerp
- Universitair Ziekenhuis Brussel - Brussels
- Cliniques Universitaires Saint-Luc - Brussels
- UZ Leuven - Leuven
- Centre Hospitalier Universitaire de Liege Sart-Tilman - Liège
- GZA Ziekenhuizen - Wilrijk
- Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês - Brasília
- CIONC-Centro Integrado de Oncologia de Curitiba - Curitiba
- Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer - Curitiba
- CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Florianópolis
Florida
- Mount Sinai Medical Center - Miami Beach
- USF College of Medicine - Tampa
Massachusetts
- Dana-Farber Cancer Institute - Boston
- Beth Israel Lahey Health - Burlington
New Jersey
- Overlook Medical Center - Summit
New South Wales
- Mater Hospital Sydney - North Sydney
Victoria
- Monash Medical Centre Moorabbin - East Bentleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-12-30 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 3 |
What NCT05950945 shows while recruiting
NCT05950945 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (91% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab Deruxtecan is the first listed.
NCT05950945 names 20 study sites across 6 states, led by Other, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05950945 about?
NCT05950945 is a clinical study titled "Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer". This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cance...
What is the current status of trial NCT05950945?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2023-12-30. Estimated completion is 2027-10-01.
What conditions does trial NCT05950945 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05950945?
The interventions under investigation include: Trastuzumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT05950945?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05950945 being conducted?
This trial has 20 study locations across Florida, Massachusetts, New Jersey, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT05950945's enrollment target sits among peer trials
250 323rd of 1224 higher than 895 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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