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NCT01772472COMPLETEDanonymous

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

PHASE3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

trastuzumab, trastuzumab emtansine

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

trastuzumab, trastuzumab emtansine

Source & freshness

Source record

NCT ID

NCT01772472

Original source

ClinicalTrials.gov

Source last updated

Jul 22, 2025

Ingested at

Jun 05, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01772472

Title

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

PHASE3

Condition raw

Breast Cancer

Condition normalized

Breast Cancer

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

trastuzumab, trastuzumab emtansine

Target normalized

trastuzumab, trastuzumab emtansine

Interventions

trastuzumab, trastuzumab emtansine

Public preview

Source record

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

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, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

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

Generated

Jun 13, 2026

NCT ID

NCT01772472

Status

COMPLETED

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Executive brief

Investment-Ready Snapshot

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJul 22, 2025
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT01772472

Indication

Breast Cancer

Modality

monoclonal antibody

Target

trastuzumab, trastuzumab emtansine

Intervention

trastuzumab, trastuzumab emtansine

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.