Metastatic Breast CancerNCT01956552
Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE)
A study testing biopsy or cytopuncture in people with Metastatic Breast Cancer, run by Institut Curie at 6 sites in France.
Trial summary
The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- biopsy or cytopuncture
- How many people
- 130 participants
- Where
- 6 sitesFrance
- Study dates
- Nov 2009to Feb 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in the study, patients must fulfill all of the following criteria:
- Female patients. Age ≥ 18 years. ECOG performance status ≤ 2. Metastatic breast carcinoma, either at diagnosis or at first metastatic relapse.
- Available FFPE +/- frozen primary tumor samples. Evaluable metastatic disease. Metastatic disease outside any previous radiotherapy field (e.g. sub-clavicular or internal mammary lymph nodes).
- Metastatic disease accessible to either percutaneous or surgical sampling. Signed written informed consent (approved by an Independent Ethics Committee and obtained prior to any study-specific screening procedure).
- Social and psychological welfare in concordance with compliance to the study.
Who cannot join
- To be eligible to participate in the study, patients must fulfill none of the following criteria:
- Bilateral or multifocal breast cancer. Isolated local or contralateral relapse.
- Solitary bone and/or brain metastatic disease unless :
- Metastatic sites eligible for a therapeutic surgery. Metastatic sites sampled for diagnosis purpose. Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin. Carcinoma in situ of the cervix. Any coagulopathy contraindicating tumor biopsy. Presence of a contraindication to general anesthesia, if required.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Oscar Lambret
Lille, 59020
Hopital Saint Louis
Paris, 75004
Institut Curie
Paris, 75005
Institut Curie HOPITAL RENE HUGUENIN
Saint-Cloud, 92210
INSTITUT DE CANCEROLOGIE DE L'OUEST René Gauducheau
Saint-Herblain, 44805
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting
The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- biopsy or cytopuncture
- Keywords
- Metastatic breast cancer, Tumor biopsy, Phenotype and genotype characterization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy or cytopunctureOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startNov 2009
- Primary completionDec 2015
- Study completionFeb 2016
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SIGAL BRIGITTE, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956552
- Sponsor's protocol ID
- IC 2009-05
- Status last verified
- Jan 2024
- First submitted
- 26 Sep 2013
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Callens C, Driouch K, Boulai A, Tariq Z, Comte A, Berger F, Belin L, Bieche I, Servois V, Legoix P, Bernard V, Baulande S, Chemlali W, Bidard FC, Fourchotte V, Salomon AV, Brain E, Lidereau R, Bachelot T, Saghatchian M, Campone M, Giacchetti S, Zafrani BS, Cottu P. Molecular features of untreated breast cancer and initial metastatic event inform clinical decision-making and predict outcome: long-term results of ESOPE, a single-arm prospective multicenter study. Genome Med. 2021 Mar 15;13(1):44. doi: 10.1186/s13073-021-00862-6.
PubMed 33722295
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting
- ClinicalTrials.gov ID
- NCT01956552
- Acronym / sponsor ID
- IC 2009-05
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, Tumor biopsy, Phenotype and genotype characterization
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Oct 2013 (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.
The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be eligible to participate in the study, patients must fulfill all of the following criteria:
- Female patients. Age ≥ 18 years. ECOG performance status ≤ 2. Metastatic breast carcinoma, either at diagnosis or at first metastatic relapse.
- Available FFPE +/- frozen primary tumor samples. Evaluable metastatic disease. Metastatic disease outside any previous radiotherapy field (e.g. sub-clavicular or internal mammary lymph nodes).
- Metastatic disease accessible to either percutaneous or surgical sampling. Signed written informed consent (approved by an Independent Ethics Committee and obtained prior to any study-specific screening procedure).
- Social and psychological welfare in concordance with compliance to the study.
Key exclusion criteria (4 listed)
- To be eligible to participate in the study, patients must fulfill none of the following criteria:
- Bilateral or multifocal breast cancer. Isolated local or contralateral relapse.
- Metastatic sites eligible for a therapeutic surgery. Metastatic sites sampled for diagnosis purpose. Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin. Carcinoma in situ of the cervix. Any coagulopathy contraindicating tumor biopsy. Presence of a contraindication to general anesthesia, if required.
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 |
|---|---|---|
| biopsy or cytopuncture | Other | – |
Primary outcome
To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression.
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 33722295Callens C, Driouch K, Boulai A, Tariq Z, Comte A, Berger F, Belin L, Bieche I, Servois V, Legoix P, Bernard V, Baulande S, Chemlali W, Bidard FC, Fourchotte V, Salomon AV, Brain E, Lidereau R, Bachelot T, Saghatchian M, Campone M, Giacchetti S, Zafrani BS, Cottu P. Molecular features of untreated breast cancer and initial metastatic event inform clinical decision-making and predict outcome: long-term results of ESOPE, a single-arm prospective multicenter study. Genome Med. 2021 Mar 15;13(1):44. doi: 10.1186/s13073-021-00862-6.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
SIGAL BRIGITTE, MD principal investigator
Institut Curie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy or cytopuncture in people with Metastatic Breast Cancer, run by Institut Curie at 6 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early. Results are not available in the source record.
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?
To assess the phenotype ant genotype discrepancies regarding hormonal receptor, FISH status and proliferation between the primary tumor and the first metastatic progression. (time frame: 2 years). 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 NCT01956552, 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 31 Jan 2024.