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Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

NCT00281658 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2023-02-10

Study results available
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Summary

This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

Lapatinib (GW572016) oral tablets

1500 mg oral daily continuously

DRUG

Paclitaxel infusion

Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months

DRUG

Placebo

Paclitaxel Matching Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-02
Primary Completion
2010-06-18
Completion
2021-11-23
FDA Drug
Yes

Countries

  • Brazil
  • China
  • Hong Kong
  • Pakistan
  • Peru
  • Russia
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00281658 on ClinicalTrials.gov