Metastatic Breast CancerSAFIR-TORNCT02444390
Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor
A study testing Biopsy in people with Metastatic Breast Cancer, run by UNICANCER at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 12 sitesFrance
- Study dates
- 19 May 2015to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut de Cancérologie de l'Ouest/Paul Papin
Angers
Centre Jean Perrin
Clermont-Ferrand
Centre Léon Bérard
Lyon
Institut de Cancérologie de l'Ouest/Rene Gauducheau
Nantes
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Clinique Armoricaine de Radiologie
Saint-Brieuc
INSTITUT DE CANCEROLOGIE Lucien Neuwirth
Saint-Priest-en-Jarez
Centre Paul Strauss
Strasbourg
Institut Claudius Regaud
Toulouse
Institut de Cancerologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy
Gustave Roussy
Villejuif
About this study
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
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.
Read the 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
- Conditions
- Metastatic Breast Cancer
- Being tested
- Biopsy
- Keywords
- Failed non steroidal aromatases inhibitors, Eligible for everolimus+exemestane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
biopsy of a metastasis
| Study group | Role | What they receive |
|---|---|---|
| Exemestane+everolimus | Other | Exemestane+everolimus are administered as per their approved indication Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the predictive value of p4EBP1 for an mTOR inhibitor efficacy
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.
Measured: from inclusion up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study start19 May 2015
- Primary completionOct 2018
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Fondation ARC
- Responsible party
- Sponsor
- Investigators
- Thomas Bachelot, MD, Principal investigator, Centre Léon Bérard, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444390
- Sponsor's protocol ID
- UC-0105/1403
- Acronym
- SAFIR-TOR
- Status last verified
- Sep 2022
- First submitted
- 11 May 2015
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vanacker H, Treilleux I, Schiffler C, Bieche I, Campone M, Patsouris A, Arnedos M, Cottu PH, Jacquin JP, Dalenc F, Pinton A, Servant N, Attignon V, Rouleau E, Morel A, Legrand F, Jimenez M, Andre F, Bachelot T. p4EBP1 staining predicts outcome in ER-positive endocrine-resistant metastatic breast cancer patients treated with everolimus and exemestane. Br J Cancer. 2024 Mar;130(4):613-619. doi: 10.1038/s41416-023-02549-8. Epub 2024 Jan 5.
PubMed 38182687
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02444390
- Acronym / sponsor ID
- SAFIR-TOR / UC-0105/1403
- Conditions
- Metastatic Breast Cancer
- Keywords
- Failed non steroidal aromatases inhibitors, Eligible for everolimus+exemestane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Novartis, Fondation ARC
- Study start
- 19 May 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane+everolimus | Other | Procedure: BiopsyExemestane+everolimus are administered as per their approved indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsybiopsy of a metastasis | Procedure or surgery | Exemestane+everolimus |
Primary outcome
the predictive value of p4EBP1 for an mTOR inhibitor efficacy
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 38182687Vanacker H, Treilleux I, Schiffler C, Bieche I, Campone M, Patsouris A, Arnedos M, Cottu PH, Jacquin JP, Dalenc F, Pinton A, Servant N, Attignon V, Rouleau E, Morel A, Legrand F, Jimenez M, Andre F, Bachelot T. p4EBP1 staining predicts outcome in ER-positive endocrine-resistant metastatic breast cancer patients treated with everolimus and exemestane. Br J Cancer. 2024 Mar;130(4):613-619. doi: 10.1038/s41416-023-02549-8. Epub 2024 Jan 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bachelot, MD principal investigator
Centre Léon Bérard, Lyon, France
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Metastatic Breast Cancer, run by UNICANCER at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the predictive value of p4EBP1 for an mTOR inhibitor efficacy (time frame: from inclusion up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.