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NCT00679341COMPLETEDanonymous

A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

PHASE2

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Source & freshness

Source record

NCT ID

NCT00679341

Original source

ClinicalTrials.gov

Source last updated

Jan 09, 2014

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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View original source fields

NCT ID

NCT00679341

Title

A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

PHASE2

Condition raw

Breast Cancer

Condition normalized

Breast Cancer

Modality raw

Breast Cancer

Modality normalized

monoclonal antibody

Target raw

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Target normalized

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Interventions

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Public preview

Source record

This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.

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 Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

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

Generated

Jun 13, 2026

NCT ID

NCT00679341

Status

COMPLETED

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Executive brief

Investment-Ready Snapshot

This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJan 09, 2014
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00679341

Indication

Breast Cancer

Modality

monoclonal antibody

Target

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Intervention

Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

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.