Last updated: 11/07/2018 16:18:20
GW572016 In Patients With Advanced Or Metastatic Breast Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase II Clinical Study of GW572016 in Patients with Advanced or Metastatic Breast Cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016
Timeframe: N/A
Secondary outcomes:
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
Timeframe: N/A
Interventions:
Drug: Tykerb
Enrollment:
59
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Toi M, Iwata H, Fujiwara Y, Wakamatsu T, Kanezaki M, Katsura K, Koehler M, Ellis C, Gagnon R, Allen K, Sasaki Y, Takashima S . Efficacy, Safety and Biomarker Findings in Patients with Advanced or Metastatic Breast Cancer Treated with Lapatinib Monotherapy: Results from 122 Japanese Patients Treated in 2 Phase II Studies. Br J Cancer. 2009;101(10):1676-1682.
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
June 2004 to December 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
20 - 40 years
Accepts healthy volunteers
No
- 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.
- Patients with certain heart problems.
Inclusion and exclusion criteria
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 location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-20-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 100642 can be found on the GSK Clinical Study Register.
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