Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06112379 · ClinicalTrials.gov registry record · Phase 3

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

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

Active
Registry status
Phase 3
Development phase
1,902
Enrollment target
20
Study locations

NCT06112379: Active Phase 3 study of Breast Cancer, sponsored by AstraZeneca.

NCT06112379 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,902 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06112379, 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
1,902 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Primary Outcome

EFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: disease progression precluding surgery, disease recurrence (local, regional, distant, or contralateral), second primary invasive cancer (other than squamous or basal cell skin cancer), or relapse from prior malignancy, or death by any cause (in the absence of recurrence). Non-invasive breast cancers and positive margins in the surgical sample do not count as an event f

Conditions Studied

Breast Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG Doxorubicin
  • DRUG Durvalumab
  • DRUG Dato-DXd
  • DRUG Epirubicin

Study Locations (20)

California

  • Research Site - Los Angeles
  • Research Site - Santa Barbara
  • Research Site - Santa Rosa
  • Research Site - Torrance

Florida

  • Research Site - Fort Myers
  • Research Site - Jacksonville
  • Research Site - St. Petersburg
  • Research Site - West Palm Beach

Arkansas

  • Research Site - Jonesboro
  • Research Site - Rogers

Colorado

  • Research Site - Aurora
  • Research Site - Longmont

Connecticut

  • Research Site - Bridgeport
  • Research Site - New Haven

Kentucky

  • Research Site - Edgewood
  • Research Site - Louisville

Alabama

  • Research Site - Daphne

Arizona

  • Research Site - Prescott

Trial Details

FieldValue
Enrollment Target 1,902 participants
Start Date 2023-11-14
Est. Completion 2032-09-23
Phase Phase 3
AstraZeneca

1,285 total trials

What the registry record for NCT06112379 still lists

NCT06112379 is an interventional study that assigns participants to a tested intervention. Its 1,902 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 (32% lower).

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

NCT06112379 names 20 study sites across 10 states, led by California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT06112379 about?

NCT06112379 is a clinical study titled "A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer". This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembroli...

What is the current status of trial NCT06112379?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,902 participants. The study started on 2023-11-14. Estimated completion is 2032-09-23.

What conditions does trial NCT06112379 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT06112379?

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

Who is sponsoring clinical trial NCT06112379?

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

Where is trial NCT06112379 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT06112379's enrollment target sits among peer trials

1,902 71st of 1224 higher than 1,154 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03729180 · 1,900 participants · NA

    The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

  • NCT05712200 · 1,900 participants · Phase 3

    Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

  • NCT06929806 · 1,900 participants · Phase 3

    Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

  • NCT07228234 · 1,900 participants · NA

    Evaluating Mammography Communication Approaches

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT06112379, the US trial registry maintained by the National Library of Medicine. NCT06112379 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.