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NCT03529110ACTIVE_NOT_RECRUITINGanonymous

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Sponsor

Source record

Daiichi Sankyo

Phase

Source record

PHASE3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Source & freshness

Source record

NCT ID

NCT03529110

Original source

ClinicalTrials.gov

Source last updated

Oct 21, 2025

Ingested at

Jun 08, 2026

Internal sync

Jun 08, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT03529110

Title

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Sponsor

Daiichi Sankyo

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE3

Condition raw

Breast Cancer

Condition normalized

Breast Cancer

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Target normalized

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Interventions

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Public preview

Source record

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT03529110

Status

ACTIVE_NOT_RECRUITING

Phase

PHASE3

Sponsor

Daiichi Sankyo

Executive brief

Investment-Ready Snapshot

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 21, 2025
Internal syncJun 08, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03529110

Indication

Breast Cancer

Modality

monoclonal antibody

Target

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Intervention

Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.