This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane are prescribed within their approved indication as per usual practice and are not part of this trial.
Estrogen hormone receptor-positive metastatic breast cancer who failed to non steroidal aromatases inhibitors in patients who are eligible for everolimus+exemestane treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
150
biopsy of a metastasis
Institut de Cancérologie de l'Ouest/Paul Papin
Angers, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Léon Bérard
Lyon, France
the predictive value of p4EBP1 for an mTOR inhibitor efficacy
The primary endpoint of the trial is the predictive value of p4EBP1 for an mTOR inhibitor efficacy, measured by the association between expression level of the biomarker (high vs low expression with a cutoff value set at the median percentages of marked cells) and clinical benefit after 6 months of everolimus+exemestane treatment.
Time frame: from inclusion up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institut de Cancérologie de l'Ouest/Rene Gauducheau
Nantes, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
INSTITUT DE CANCEROLOGIE Lucien Neuwirth
Saint-Priest-en-Jarez, France
Centre Paul Strauss
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
...and 2 more locations