Clinical Trials Logo
  1. Home
  2. Neoplasms, Breast
  3. NCT00462956
  4. Details
NCT00462956 Clinical Trial

GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Neoplasms, Breast Clinical Trial

Official title:
Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00462956
Other study ID # EGF100642
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 30, 2004
Est. completion date December 20, 2006

Study information
Verified date August 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date December 20, 2006
Est. primary completion date December 20, 2006
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tykerb
lapatinib 1500mg daily

Locations
Country Name City State
GSK Investigational Site
Japan GSK Investigational Site Ehime
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Saitama
Japan GSK Investigational Site Tochigi
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016
Secondary Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue
See also
  Status Clinical Trial Phase
Terminated NCT00251433 - GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer Phase 1
Completed NCT01271738 - Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer N/A
Recruiting NCT04892342 - Study of ESG401 in Adults With Solid Tumors Phase 1/Phase 2
Terminated NCT02213042 - Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Phase 2
Withdrawn NCT01137994 - A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer Phase 2
Completed NCT00790816 - Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents Phase 1
Completed NCT00051103 - Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin. Phase 2
Completed NCT00320411 - GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer Phase 2
Completed NCT00258050 - To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients Phase 1
Terminated NCT01498588 - Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer Phase 2
Terminated NCT00479856 - Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer Phase 2
Completed NCT00320385 - Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer Phase 3
Completed NCT00062686 - GW572016 For Treatment Of Refractory Metastatic Breast Cancer Phase 2
Completed NCT00996762 - A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib Phase 1
Terminated NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation N/A
Completed NCT01160211 - A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer Phase 3
Recruiting NCT05814224 - Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA N/A
Completed NCT01815294 - A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer Phase 1
Terminated NCT00437073 - Brain Metastases In ErbB2-Positive Breast Cancer Phase 2
Completed NCT00356811 - Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer Phase 2

External Links