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SAFIR-TOR: Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor

Sponsor
UNICANCER (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02444390
Collaborator
Novartis (Industry), Fondation ARC (Other)
150
Enrollment
12
Locations
1
Arm
88.4
Anticipated Duration (Months)
12.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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
Actual Study Start Date :
May 19, 2015
Actual Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Exemestane+everolimus

Exemestane+everolimus are administered as per their approved indication

Procedure: Biopsy
biopsy of a metastasis

Outcome Measures

Primary Outcome Measures

  1. the predictive value of p4EBP1 for an mTOR inhibitor efficacy [from inclusion up to 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Progressive disease under endocrine therapy at the time of inclusion

  2. Treatment with everolimus and exemestane not yet started

  3. Patients with metastases that can be biopsied, except bone metastases

  4. Measurable or evaluable disease

  5. Age ≥18 years

  6. WHO Performance Status 0/1

  7. Provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy

  8. 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

  1. Abnormal coagulation or any other medical situation contraindicating biopsy

  2. Bone metastases when this is the only site of biopsiable disease

  3. 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

  4. Individuals deprived of liberty or placed under the authority of a tutor

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Cancérologie de l'Ouest/Paul Papin Angers France
2 Centre Jean Perrin Clermont-Ferrand France
3 Centre Léon Bérard Lyon France
4 Institut de Cancérologie de l'Ouest/Rene Gauducheau Nantes France
5 Centre Antoine Lacassagne Nice France
6 Institut Curie Paris France
7 Clinique Armoricaine de Radiologie Saint-Brieuc France
8 INSTITUT DE CANCEROLOGIE Lucien Neuwirth St PRIEST EN JAREZ France
9 Centre Paul Strauss Strasbourg France
10 Institut Claudius Regaud Toulouse France
11 Institut de Cancerologie de Lorraine Alexis Vautrin Vandoeuvre-les-nancy France
12 Gustave Roussy Villejuif France

Sponsors and Collaborators

  • UNICANCER
  • Novartis
  • Fondation ARC

Investigators

  • Principal Investigator: Thomas Bachelot, MD, Centre Léon Bérard, Lyon, France

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
UNICANCER
ClinicalTrials.gov Identifier:
NCT02444390
Other Study ID Numbers:
  • UC-0105/1403
First Posted:
May 14, 2015
Last Update Posted:
Nov 4, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by UNICANCER
Failed non steroidal aromatases inhibitors
Eligible for everolimus+exemestane
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Nov 4, 2021