Sign inCreate account

Report workspace tools

NCT01513083COMPLETEDanonymous

A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Sponsor

Source record

Hoffmann-La Roche

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

trastuzumab emtansine

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

trastuzumab emtansine

Source & freshness

Source record

NCT ID

NCT01513083

Original source

ClinicalTrials.gov

Source last updated

Nov 02, 2016

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01513083

Title

A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Sponsor

Hoffmann-La Roche

Status

COMPLETED

Phase

PHASE1

Condition raw

Breast Cancer

Condition normalized

Breast Cancer

Modality raw

Breast Cancer

Modality normalized

monoclonal antibody

Target raw

trastuzumab emtansine

Target normalized

trastuzumab emtansine

Interventions

trastuzumab emtansine

Public preview

Source record

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

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

Report access

Create an account to unlock this report

Choose the access model that matches the job: one urgent report, reusable credits for project work, or unlimited monthly access with AI and folders.

Full protocol, outcomes, eligibility, contacts and results sections
Patent/IP landscape with verified records when available
Board-ready PDF export with source provenance
Save to folders and synthesize multiple assets in premium workspace
Create account
Sign in

Create a free account first, then unlock a single report, buy credits or subscribe.

TrialSignal

Clinical trial intelligence report

A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

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

Generated

Jun 13, 2026

NCT ID

NCT01513083

Status

COMPLETED

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Executive brief

Investment-Ready Snapshot

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedNov 02, 2016
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT01513083

Indication

Breast Cancer

Modality

monoclonal antibody

Target

trastuzumab emtansine

Intervention

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.