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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 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.

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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.

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

FieldValue
Enrollment Target 250 participants
Start Date 2023-12-30
Est. Completion 2027-10-01
Phase Phase 3

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT05950945

The ClinicalTrials.gov registry entry for NCT05950945 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.