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NCT04494425 · ClinicalTrials.gov registry record · Phase 3

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

A Phase 3 study of Advanced or Metastatic Breast Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
866
Enrollment target
20
Study locations

NCT04494425 is a Phase 3 study of Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 866 participants, above the 136-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (537% higher). The trial reports 20 study locations across 18 states.

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The verdict

NCT04494425, a Phase 3 study of Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

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

Study Summary

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Conditions Studied

Advanced or Metastatic Breast Cancer

Interventions

  • DRUG Capecitabine
  • DRUG Paclitaxel
  • DRUG Nab-Paclitaxel
  • DRUG Trastuzumab deruxtecan

Study Locations (20)

California

  • Research Site - Duarte
  • Research Site - Los Angeles

Colorado

  • Research Site - Aurora
  • Research Site - Lakewood

Arizona

  • Research Site - Scottsdale

Arkansas

  • Research Site - Springdale

District of Columbia

  • Research Site - Washington D.C.

Florida

  • Research Site - Jacksonville

Kansas

  • Research Site - Kansas City

Kentucky

  • Research Site - Louisville

Trial Details

FieldValue
Enrollment Target 866 participants
Start Date 2020-07-24
Est. Completion 2026-06-19
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT04494425

The ClinicalTrials.gov registry entry for NCT04494425 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 866 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 136-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (537% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.

NCT04494425 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Colorado, Arizona.

Frequently Asked Questions

What is clinical trial NCT04494425 about?

NCT04494425 is a clinical study titled "Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer". This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in t...

What is the current status of trial NCT04494425?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 866 participants. The study started on 2020-07-24. Estimated completion is 2026-06-19.

What conditions does trial NCT04494425 study?

This clinical trial studies the following conditions: Advanced or Metastatic Breast Cancer.

What interventions are being tested in trial NCT04494425?

The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), Nab-Paclitaxel (DRUG), Trastuzumab deruxtecan (DRUG).

Who is sponsoring clinical trial NCT04494425?

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

Where is trial NCT04494425 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. 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.