MedTrace Logo

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 625

Last updated 2026-04-30

No results posted yet for this study

Summary

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Conditions

Interventions

DRUG

Dato-DXd

Provided in 100mg vials. IV infusion. Experimental drug.

DRUG

Durvalumab

Provided in 500mg vials. IV infusion. Experimental drug.

DRUG

Paclitaxel

IV infusion. Active comparator.

DRUG

Nab-paclitaxel

IV infusion. Active comparator.

DRUG

Gemcitabine

IV infusion. Active comparator.

DRUG

Carboplatin

IV infusion. Active comparator.

DRUG

Pembrolizumab

IV infusion. 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
2023-11-23
Primary Completion
2027-07-28
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Mexico
  • Philippines
  • Poland
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • 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 NCT06103864 on ClinicalTrials.gov