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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.
Full description
Estrogen hormone receptor-positive metastatic breast cancer who failed to non steroidal aromatases inhibitors in patients who are eligible for everolimus+exemestane treatment
Enrollment
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Volunteers
Inclusion criteria
Women (or men) with histologically-proven Estrogen Receptor-positive (ER+) and/or Progesterone Receptor-positive (PR+) / Human Epidermal growth factor Receptor 2-negative (HER2-) metastatic breast adenocarcinoma or locally advanced disease who cannot be treated with surgery and/or radiation therapy
Postmenopausal women
Asymptomatic if visceral disease
Second line hormonotherapy or more for metastatic or locally advanced disease after recurrence or progression following a non-steroidal aromatase inhibitor (in adjuvant or metastatic setting)
Progressive disease under endocrine therapy at the time of inclusion
Treatment with everolimus and exemestane not yet started
Patients with metastases that can be biopsied, except bone metastases
Measurable or evaluable disease
Age ≥18 years
WHO Performance Status 0/1
Provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy
Patient with social insurance coverage
Exclusion criteria
Contraindications for everolimus+exemestane treatment
Previous treatment with an anti-mTOR therapy
More than 1 previous line of chemotherapy in metastatic setting
Life expectancy <3 months
Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug)
Haematopoietic function or organ impairment as shown by the following criteria:
Abnormal coagulation or any other medical situation contraindicating biopsy
Bone metastases when this is the only site of biopsiable disease
Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
Individuals deprived of liberty or placed under the authority of a tutor
Primary purpose
Allocation
Interventional model
Masking
150 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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