GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

Phase I Study of Lapatinib in Combination With Trastuzumab

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371488

Enrollment

Registered

2006-09-04

Start date

2006-04-06

Completion date

2007-12-10

Last updated

2018-08-31

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

Conditions

Neoplasms, Breast

Keywords

ErbB2, Stage IV breast cancer, ErbB1, breast cancer, lapatinib, Herceptin, trastuzumab

Brief summary

This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.

Interventions

DRUGGW572016 oral tablets

Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Patients with confirmed breast cancer who have received prior trastuzumab. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly	6 Months	To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.

Secondary

Measure	Time frame
Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue	6 Months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026