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Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

NCT00667251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2025-03-21

Study results available
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Summary

This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.

Conditions

Interventions

BIOLOGICAL

trastuzumab

IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).

DRUG

docetaxel

75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).

DRUG

lapatinib ditosylate

1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).

DRUG

paclitaxel

80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • Novartis pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-07
Primary Completion
2012-08-01
Completion
2022-07-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
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 NCT00667251 on ClinicalTrials.gov