- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02444390
Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor (SAFIR-TOR)
Identification of the Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor of HR+ Metastatic Breast Cancer in Post-menopausal Women
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Angers, Frankrike
- Institut de Cancérologie de l'Ouest/Paul Papin
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Clermont-Ferrand, Frankrike
- Centre Jean Perrin
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Lyon, Frankrike
- Centre Léon Bérard
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Nantes, Frankrike
- Institut de Cancérologie de l'Ouest/Rene Gauducheau
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Nice, Frankrike
- Centre Antoine Lacassagne
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Paris, Frankrike
- Institut Curie
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Saint-Brieuc, Frankrike
- Clinique Armoricaine de Radiologie
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St PRIEST EN JAREZ, Frankrike
- Institut de Cancérologie Lucien Neuwirth
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Strasbourg, Frankrike
- Centre Paul Strauss
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Toulouse, Frankrike
- Institut Claudius Regaud
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Vandoeuvre-les-nancy, Frankrike
- Institut de Cancérologie de Lorraine Alexis Vautrin
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Villejuif, Frankrike
- Gustave Roussy
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Eligible for everolimus+exemestane treatment as required by the marketing authorisation conditions
- 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)
- Eligible for the biopsy
- 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:
- Polynuclear neutrophils <1.5 x 10⁹/L
- Platelets <100 x 10⁹/L
- Haemoglobin <90 g/L
- Alanine aminotransferase (ALAT) / aspartate aminotransferase (ASAT) >2.5 x ULN in the absence of or >5 x upper limit of normal (ULN) in the presence of liver metastases
- Bilirubin >1.5 x ULN
- Creatinine clearance ≤50 mL/min (measured or calculated by Cockcroft and Gault formula)
- Calcium and phosphate >ULN
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Exemestane+everolimus
Exemestane+everolimus are administered as per their approved indication
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biopsy of a metastasis
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
the predictive value of p4EBP1 for an mTOR inhibitor efficacy
Tidsram: from inclusion up to 6 months
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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.
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from inclusion up to 6 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Thomas Bachelot, MD, Centre Léon Bérard, Lyon, France
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UC-0105/1403
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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