This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Institut Jules Bordet
Brussels, Belgium
Grand Hopital de Charleroi
Charleroi, Belgium
CMSE
Namur, Belgium
Institut Curie
Paris, France
Institut de Cancérologie Gustave Roussy
HES4 gene expression level
To demonstrate that PF-03084014 is able to modulate the Notch pathway by down-regulating the expression of the tumor HES4 gene in chemoresistant TNBC (evaluable population).
Time frame: tumour tissue samples before study drug and after 9 days of study drug. General analysis after all patients included.
Safety: General assesment of number and grade of adverse events after short(9-day) administration of oral PF-03084014 in patients with chemoresistant TNBC.
Patients will be followed for Adverse Events and Serious Adverse Events from the first dose of study drug up to 28 days after the last dose.
Time frame: adverse events followed up to 28 days after last PF-03084014 dose.
Transcriptome analysis (changes in the HES4 gene expression and tumor transcriptome)
To assess changes in the HES4 gene expression and tumor transcriptome for all patients registered in the RHEA study (intent-to-treat population)
Time frame: tissue samples before study drug and after 9 days of study drug. General analysis after all patients included.
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Villejuif, France