Clinical Trials /

Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor

NCT02444390

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: UC-0105/1403
  • NCT ID: NCT02444390

Conditions

  • Metastatic Breast Cancer

Purpose

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.

Detailed Description

      Estrogen hormone receptor-positive metastatic breast cancer who failed to non steroidal
      aromatases inhibitors in patients who are eligible for everolimus+exemestane treatment
    

Trial Arms

NameTypeDescriptionInterventions
Exemestane+everolimusOtherExemestane+everolimus are administered as per their approved indication

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Eligible for everolimus+exemestane treatment as required by the marketing
                 authorisation conditions
    
                   1. Women (or men) with histologically-proven ER+ and/or PR+ /HER2- metastatic breast
                      adenocarcinoma or locally advanced disease who cannot be treated with surgery
                      and/or radiation therapy
    
                   2. postmenopausal women
    
                   3. asymptomatic if visceral disease
    
                   4. 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
    
                   5. Progressive disease under endocrine therapy at the time of inclusion
    
                   6. Treatment with everolimus and exemestane not yet started
    
                   7. Patients with metastases that can be biopsied, except bone metastases
    
                   8. Measurable or evaluable disease
    
                   9. Age ≥ 18 years
    
                  10. WHO Performance Status 0/1
    
                  11. Provision of signed and dated, written informed consent prior to any protocol
                      specific procedure, including biopsy
    
                  12. Patient with social insurance coverage
    
            Exclusion Criteria:
    
              -  1. Contraindications for everolimus+exemestane treatment 2. Previous treatment with an
                 anti-mTOR therapy 3. More than 1 previous line of chemotherapy in metastatic setting
                 4. Life expectancy <3 months, 5. 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).
    
                 6. 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
    
                   -  ALAT/ASAT > 2.5x ULN in the absence of or > 5x ULN in the presence of liver
                      metastases
    
                   -  bilirubin > 1.5xULN
    
                   -  creatinine clearance ≤50 mL/min (measured or calculated by Cockroft and Gault
                      formula)
    
                   -  calcium and phosphate > ULN 7. Abnormal coagulation or any other medical
                      situation contraindicating biopsy 8. Bone metastases when this is the only site
                      of biopsiable disease 9. 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.
    
                      10. Individuals deprived of liberty or placed under the authority of a tutor.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:the predictive value of p4EBP1 for an mTOR inhibitor efficacy
    Time Frame:from inclusion up to 6 months
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:UNICANCER

    Trial Keywords

    • Failed non steroidal aromatases inhibitors
    • Eligible for everolimus+exemestane

    Last Updated

    May 2, 2017