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NCT05629585 · ClinicalTrials.gov registry record · Phase 3

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

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

Active
Registry status
Phase 3
Development phase
1,174
Enrollment target
20
Study locations

NCT05629585: Active Phase 3 study of Breast Cancer, sponsored by AstraZeneca.

NCT05629585 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,174 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05629585, 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
1,174 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

Primary Outcome

iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive

Conditions Studied

Breast Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG Capecitabine
  • DRUG Durvalumab
  • DRUG Dato-DXd

Study Locations (20)

California

  • Research Site - Beverly Hills
  • Research Site - Costa Mesa
  • Research Site - Duarte
  • Research Site - Fountain Valley
  • Research Site - Irvine
  • Research Site - La Jolla
  • Research Site - Lakewood
  • Research Site - Los Angeles
  • Research Site - Los Angeles
  • Research Site - Newport Beach
  • Research Site - Newport Beach
  • Research Site - Orange
  • Research Site - Roseville
  • Research Site - Upland

Arizona

  • Research Site - Gilbert
  • Research Site - Tucson
  • Research Site - Tucson

Arkansas

  • Research Site - Hot Springs
  • Research Site - Little Rock
  • Research Site - Springdale

Trial Details

FieldValue
Enrollment Target 1,174 participants
Start Date 2022-11-28
Est. Completion 2030-01-30
Phase Phase 3
AstraZeneca

1,285 total trials

What the registry record for NCT05629585 still lists

NCT05629585 is an interventional study that assigns participants to a tested intervention. Its 1,174 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower).

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

NCT05629585 names 20 study sites across 3 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05629585 about?

NCT05629585 is a clinical study titled "A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)". This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgica...

What is the current status of trial NCT05629585?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,174 participants. The study started on 2022-11-28. Estimated completion is 2030-01-30.

What conditions does trial NCT05629585 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05629585?

The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Durvalumab (DRUG), Dato-DXd (DRUG).

Who is sponsoring clinical trial NCT05629585?

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

Where is trial NCT05629585 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. 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 NCT05629585's enrollment target sits among peer trials

1,174 108th of 1224 higher than 1,117 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 NCT05629585, the US trial registry maintained by the National Library of Medicine. NCT05629585 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.