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

Unicancer logo

Unicancer

Status

Completed

Conditions

Metastatic Breast Cancer

Treatments

Procedure: Biopsy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02444390
UC-0105/1403

Details and patient eligibility

About

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

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Exemestane+everolimus
Other group
Description:
Exemestane+everolimus are administered as per their approved indication
Treatment:
Procedure: Biopsy

Trial documents
1

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems