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NCT05374512 · ClinicalTrials.gov registry record · Phase 3

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

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

Active
Registry status
Phase 3
Development phase
644
Enrollment target
20
Study locations

NCT05374512: Active Phase 3 study of Breast Cancer, sponsored by AstraZeneca.

NCT05374512 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 644 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05374512, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

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

Study Summary

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Primary Outcome

PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at

Conditions Studied

Breast Cancer

Interventions

  • DRUG Carboplatin
  • DRUG Capecitabine
  • DRUG Paclitaxel
  • DRUG Nab-paclitaxel
  • DRUG Dato-DXd

Study Locations (20)

California

  • Research Site - Duarte
  • Research Site - Los Angeles
  • Research Site - San Francisco

Colorado

  • Research Site - Grand Junction
  • Research Site - Longmont

Florida

  • Research Site - Miami
  • Research Site - Miami

North Carolina

  • Research Site - Charlotte
  • Research Site - Winston-Salem

Tennessee

  • Research Site - Memphis
  • Research Site - Nashville

Connecticut

  • Research Site - New Haven

District of Columbia

  • Research Site - Washington D.C.

Georgia

  • Research Site - Atlanta

Trial Details

FieldValue
Enrollment Target 644 participants
Start Date 2022-05-16
Est. Completion 2028-11-03
Phase Phase 3
AstraZeneca

1,285 total trials

What the registry record for NCT05374512 still lists

NCT05374512 is an interventional study that assigns participants to a tested intervention. The registered 644 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 (77% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT05374512 names 20 study sites across 14 states, led by California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT05374512 about?

NCT05374512 is a clinical study titled "A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)". This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

What is the current status of trial NCT05374512?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2022-05-16. Estimated completion is 2028-11-03.

What conditions does trial NCT05374512 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05374512?

The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Dato-DXd (DRUG).

Who is sponsoring clinical trial NCT05374512?

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

Where is trial NCT05374512 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. 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 NCT05374512's enrollment target sits among peer trials

644 169th of 1224 higher than 1,055 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05374512, the US trial registry maintained by the National Library of Medicine. NCT05374512 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.