Status:
COMPLETED
Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the over...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)
- Estrogen Receptor \[ER\] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)
- No more than 1 prior chemotherapy received for treating this metastatic breast cancer
- No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)
- Other protocol-defined inclusion criteria may apply
Exclusion
- Prior platinum agent
- Prior mitomycin
- Known history of brain metastases
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00463788
Start Date
June 1 2007
End Date
February 1 2011
Last Update
February 13 2014
Active Locations (46)
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1
Research Site
Campbelltown, New South Wales, Australia
2
Research Site
Liverpool, New South Wales, Australia
3
Research Site
Wollongong, New South Wales, Australia
4
Research Site
Malvern, Victoria, Australia