GW572016 In Patients With Advanced Or Metastatic Breast Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Breast

Treatments: Drug: Tykerb

Study type: Interventional

Funder types: Industry

Identifiers

NCT00462956

EGF100642

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.

Enrollment: 59 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
• Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
• Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria

• Patients with certain heart problems.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

59 participants in 1 patient group

lapatinib 1500mg daily

Experimental group

Description:

Subjects will self-administer lapatinib 1500 mg orally once daily.

Treatment:

Drug: Tykerb