NCT05374512|Active Not RecruitingPhase 3DMCFDA Drug

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

AstraZeneca ClinicalTrials.gov

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3 other identifiers

D926PC000012023-509260-252021-005223-21

Study Type

interventional

Target

644

Locations

23 countries

Sites

228

Timeline

RegisteredMay 2022

StartedMay 2022

CompletionNov 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

644

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline

31mo left

Started May 2022

Typical duration for phase_3 breast-cancer

Geographic Reach

23 countries

228 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

Study Progress61%

May 2022Nov 2028

First Submitted

Initial submission to the registry

April 19, 2022

Completed

27 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed

Same day until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed

3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2028

Expected

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

April 19, 2022

Last Update Submit

January 26, 2026

Conditions

Breast Cancer

Keywords

Breast Cancer;PD-1/PD-L1 Therapy;Dato-DXd; DS1062a;TROP2;Triple-negative;Metastatic; Inoperable;Datopotamab deruxtecan;Antibody Drug Conjugate;ADC

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS)
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 the time of the latest evaluable assessment prior to the 2 missed visits. The measure of interest is the hazard ratio \[HR\] of PFS.
From randomization until progression as assessed by BICR or death due to any cause (anticipated to be up to 26 months)
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, by treatment group as randomised. The measure of interest is the hazard ratio \[HR\] of OS.
From randomisation until the date of death due to any cause (approximately 42 months)

Secondary Outcomes (14)

Objective Response Rate (ORR)
From randomisation up until progression (anticipated to be up to 26 months)
Duration of Response (DoR)
From the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause (anticipated to be up to 26 months)
Progression-Free Survival (PFS) by Investigator assessment
From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 26 months)
Disease Control Rate (DCR)
At least 11 weeks after randomization to 23 months
Time to deterioration (TTD) in pain in participants treated with Dato DXd compared with ICC
From the date of randomisation to the date of deterioration (from randomization to 18 weeks post-progression)
+9 more secondary outcomes

Study Arms (2)

Dato-DXd

EXPERIMENTAL

Arm 1: Dato-DXd

Drug: Dato-DXd

Investigator's Choice of Chemotherapy (ICC)

ACTIVE COMPARATOR

Arm 2: If no prior taxane, or prior taxane in the (neo)adjuvant setting and DFI \> 12 months, paclitaxel or nab-paclitaxel If prior taxane and DFI ≤ 12 months: capecitabine, carboplatin, or eribulin.

Drug: PaclitaxelDrug: Nab-paclitaxelDrug: CarboplatinDrug: CapecitabineDrug: Eribulin mesylate