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 (BALI-1)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.
The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- Prior platinum agent
- Prior mitomycin
- Known history of brain metastases
- Other protocol-defined exclusion criteria may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
181 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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