Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer

NCT00422903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-05-12

Study results available
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Summary

Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole

Conditions

  • Neoplasms, Breast

Interventions

DRUG

lapatinib

1500 mg administered orally daily

DRUG

letrozole

2.5 mg administered orally daily

OTHER

placebo

1500 mg administered orally daily

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Italy
  • Spain

Study Locations

More Related Trials

Entities

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 NCT00422903 on ClinicalTrials.gov