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NCT05113251 · ClinicalTrials.gov registry record · Phase 3

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

A Phase 3 study of Breast Cancer and Breast Neoplasms, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
927
Enrollment target
20
Study locations

NCT05113251 is a Phase 3 study of Breast Cancer and Breast Neoplasms that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 927 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05113251, a Phase 3 study of Breast Cancer and Breast Neoplasms, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
927 participants
Enrollment target
20
Study locations

Study Summary

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

Interventions

  • DRUG Trastuzumab
  • DRUG Doxorubicin
  • DRUG Paclitaxel
  • DRUG Trastuzumab Deruxtecan
  • DRUG Pertuzumab

Study Locations (20)

California

  • Research Site - Beverly Hills
  • Research Site - Glendale
  • Research Site - Los Alamitos
  • Research Site - Orange

Kentucky

  • Research Site - Lexington
  • Research Site - Louisville

New Jersey

  • Research Site - East Brunswick
  • Research Site - Summit

Tennessee

  • Research Site - Germantown
  • Research Site - Nashville

Arkansas

  • Research Site - Springdale

Connecticut

  • Research Site - New Haven

Indiana

  • Research Site - Fort Wayne

Louisiana

  • Research Site - Shreveport

Trial Details

FieldValue
Enrollment Target 927 participants
Start Date 2021-10-25
Est. Completion 2027-04-30
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT05113251

The ClinicalTrials.gov registry entry for NCT05113251 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 927 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 (67% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.

NCT05113251 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Kentucky, New Jersey.

Frequently Asked Questions

What is clinical trial NCT05113251 about?

NCT05113251 is a clinical study titled "Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer". This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

What is the current status of trial NCT05113251?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 927 participants. The study started on 2021-10-25. Estimated completion is 2027-04-30.

What conditions does trial NCT05113251 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms, HER2-positive Early Breast Cancer.

What interventions are being tested in trial NCT05113251?

The interventions under investigation include: Trastuzumab (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Trastuzumab Deruxtecan (DRUG), Pertuzumab (DRUG).

Who is sponsoring clinical trial NCT05113251?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05113251 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Indiana, Kentucky. 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.