A phase III, randomized, open-label, multicenter study comparing GW572016 and Capecitabile (Xeloda) versus Capecitabile in women with refractory advanced or metastatic breast cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001456-36-IT

Enrollment

372

Registered

2005-12-23

Start date

2004-09-06

Completion date

Unknown

Last updated

2012-12-10

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: 15.1 Level: PT Classification code 10006279 Term: Breast neoplasm 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: lapatinib Current Sponsor code: GW572016 Concentration unit: mg milligram(s) Concentration number: 250-

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

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

Countries

Italy

Outcome results

None listed

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