FindTrial
Sign In

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing GW572016 and Letrozole versus Letrozole in Subjects with Estrogen/Progesterone Receptor-Positive Advanced or Metastatic Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing GW572016 and Letrozole versus Letrozole in Subjects with Estrogen/Progesterone Receptor-Positive Advanced or Metastatic Breast Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-003928-35-IT
Enrollment
15
Registered
2005-09-20
Start date
2005-06-16
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor treatment MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Lapatinib Product Code: GW572016 Pharmaceutical Form: Tablet INN or Proposed INN: Other antineoplastic agents Current Sponsor code: GW572016 Concentration unit: mg milligram(s) Concentra

Sponsors

GLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Contacts

Public ContactCLINICAL TRIALS HELPDESK

GlaxoSmithkline Research & Development Ltd

GSKClinicalSupportHD@gsk.com800786766 opp +44 20 8990 4466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026