Status:
TERMINATED
Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection and characterization of circulating tumour cells in cancer patients has p...
Detailed Description
Rationale: Despite recent progress in gene-expression profiling studies, the underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection ...
Eligibility Criteria
Inclusion
- Female patients at least 18 years old with HER-2 negative breast cancer.
- Patients must have evidence of HER-2 or EGFR positive circulating tumour cells in a peripheral blood sample taken at screening visit.
- Patients must have measurable, metastatic disease and no brain metastasis requiring local therapy.
- Other criteria include ECOG score 0 to 2, life expectancy \> 12 weeks, baseline organ function at screening visit,
- Previous treatment with anthracyclines and/or taxanes in the neo-adjuvant, adjuvant or advanced setting, and at least one line of treatment for metastatic disease.
Exclusion
- Unstable medical conditions, pregnant or lactating women.
- Inability to provide informed consent.
- Lack of physical integrity of the upper gastrointestinal (GI) tract.
- Co-existing malignancy or malignancies within the last 5 years with the exception of basal cell carcinoma or in-situ carcinoma, concurrent anti-cancer therapies (chemo or hormonal therapy) or investigational drugs other than study drug.
- Concurrent radiotherapy to the only target lesion or concurrent bisphosphonates if bone metastases are the only target lesions.
- Previous treatment with anti HER-2 or anti-EGFR therapies.
- Protocol specified treatment regimens that would be inappropriate for the management of the subject.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00820924
Start Date
June 1 2008
End Date
July 1 2011
Last Update
March 28 2012
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
2
GSK Investigational Site
Udine, Friuli Venezia Giulia, Italy, 33100
3
GSK Investigational Site
Bergamo, Lombardy, Italy, 24128
4
GSK Investigational Site
Milan, Lombardy, Italy, 20121