Breast Neoplasm Clinical Trial
Official title:
Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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