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A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer

NCT01526369 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-09

No results posted yet for this study

Summary

The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

Conditions

Interventions

DRUG

Trastuzumab

DRUG

Paclitaxel

DRUG

Lapatinib

Sponsors & Collaborators

  • Cancer Trials Ireland

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-13
Primary Completion
2015-11-30
Completion
2023-02-17

Countries

  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Norway
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526369 on ClinicalTrials.gov