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.
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
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
Name | Type | Description | Interventions |
---|
Exemestane+everolimus | Other | Exemestane+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 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
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
- 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
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: | Active, not recruiting |
Lead Sponsor: | UNICANCER |
Trial Keywords
- Failed non steroidal aromatases inhibitors
- Eligible for everolimus+exemestane
Last Updated
November 4, 2020