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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

NCT06112379 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1902

Last updated 2026-04-02

No results posted yet for this 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.

Conditions

Interventions

DRUG

Dato-DXd

Experimental drug IV infusion

DRUG

Durvalumab

Experimental drug IV Infusion

DRUG

Pembrolizumab

IV Infusion Active comparator

DRUG

Doxorubicin

IV infusion Experimental/Active Comparator

DRUG

Epirubicin

IV Infusion Experimental/Active Comparator

DRUG

Cyclophosphamide

IV infusion Experimental/Active Comparator

DRUG

Paclitaxel

IV infusion Experimental/Active Comparator

DRUG

Carboplatin

IV infusion Experimental/Active Comparator

DRUG

Capecitabine

Tablet Oral route of administration Experimental/Active Comparator

DRUG

Olaparib

Tablet Oral route of administration Experimental/Active Comparator

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2028-11-20
Completion
2032-09-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112379 on ClinicalTrials.gov