Metastatic Breast CancerMIRRORNCT02626039
Characterization & Comparison of Drugable Mutations in Primary and Metastatic Tumors, CTCs and cfDNA in MBCpatients
An observational study of Metastatic Breast Cancer, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Characterization of the driver mutations in an individual metastatic breast cancer patient is critical for many reasons. Effective targeted therapies require identifying genomic alterations in the tumoral tissue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Aug 2018
- Phase
- Observational
- 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
Study population: Women with metastatic breast cancer in which FFPE samples from the primary tumors are available and in whom a biopsy of the metastatic relapse is clinically indicated. Investigators will offer enrollment to consecutively seen women who meet the entry criteria. Target enrollment is 40 patients
Who may be able to join
- Metastatic breast cancer confirmed by radiologic findings
- ≥ 18 years old
- Able to give signed consent
- Availability to get the paraffin block of her primary tumor.
- First metastatic relapse or tumor regrowth while on treatment for metastatic disease (progressive disease while on treatment)
- Biopsy of the metastatic site clinically indicated
Who cannot join
- Inability to get a core sample from a metastatic site
- Bone disease only (the decalcification process usually prevents an appropriate genomic study).
- Unable to drawn peripheral blood
- Unable to give the informed consent
- Coagulation disorders
- ECOG status 3-4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization and Comparison of Drugable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells and Cell-Free Circulating DNA in Metastatic Breast Cancer Patients
Characterization of the driver mutations in an individual metastatic breast cancer patient is critical for many reasons. Effective targeted therapies require identifying genomic alterations in the tumoral tissue. The scarce efficacy of many currently available targeted drugs may be due to the outbreak of resistant clones with different genotype that already present at the initiation of therapy. It is well known the intra-tumor heterogeneity with genetic and non-genetic factors considered as the origin of the tumor cell-clon composition. The acquisition of multiple mutations (driver and passenger), altogether with the stage of differentiation, according to the cancer stem cell hypothesis, confers to the tumor cells clinically important properties, such as resistance to therapies and seeding abilities.
Moreover, there is a current challenge in establishing whether the metastatic cells arise from the most aggressive and dominant clone in the primary tumor or the metastasic tissue diverges with substantial genetic changes very early in the evolution of the disease. Primary and metastatic tumor may have a close clonal relationship or evolve in parallel and acquire different genomic alterations. In the real life, it is plausible that both models coexist with different predominance according to the tumoral tissue and etiology.
Read more
The study hypothesizes that breast cancer metastases and primary tumors could harbor different genomic profiles related to genomic regions of interest in a clinically relevant proportion of metastatic breast cancer patients.
Moreover, the genomic aberrations found in the metastatic breast cancer tissue could also be detected in CTCs and circulating free DNA.
If true, CTCs and circulating free DNA would be convenient, non-invasive, easily accessible sources of genomic material for the analysis of mutations and other genomic aberrations.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, CTCs, cfDNA, genomics, somatic mutations
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen's kappa coefficient to measure the inter-rater agreement for mutations and other genomic findings (categorical items) between the metastatic tissue and the primary tumor tissue in Metastatic Breast Cancer patients.
Measured: 26 months
Secondary outcomes (2)
Number of somatic genomic findings (found in the primary and metastatic tumor) in circulating tumoral cells (CTC) and circulating free DNA(cfDNA) obtained from peripheral blood (liquid biopsy).
Measured: 26 months
Description of the mutations in analyzed genes in the primary tumor and in CTC/cfDNA for each patient.
Note: circulating tumor cells couldn't be sequenced
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startNov 2013
- Primary completionJul 2018
- Study completionAug 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Martín, Ph, Study chair, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626039
- Sponsor's protocol ID
- GOMHGUGM092013
- Acronym
- MIRROR
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2015
- Last updated
- 11 Aug 2020
- Results posted
- No
Publications
Gonzalez-Rivera M, Picornell AC, Alvarez EL, Martin M. A Cross-Sectional Comparison of Druggable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells, and Cell-Free Circulating DNA in Patients with Metastatic Breast Cancer: The MIRROR Study Protocol. JMIR Res Protoc. 2016 Aug 16;5(3):e167. doi: 10.2196/resprot.6024.
PubMed 27531554
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Comparison of Drugable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells and Cell-Free Circulating DNA in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02626039
- Acronym / sponsor ID
- MIRROR / GOMHGUGM092013
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, CTCs, cfDNA, genomics, somatic mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Dec 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.
Characterization of the driver mutations in an individual metastatic breast cancer patient is critical for many reasons. Effective targeted therapies require identifying genomic alterations in the tumoral tissue. The scarce efficacy of many currently available targeted drugs may be due to the outbreak of resistant clones with different genotype that already present at the initiation of therapy. It is well known the intra-tumor heterogeneity with genetic and non-genetic factors considered as the origin of the tumor cell-clon composition. The acquisition of multiple mutations (driver and passenger), altogether with the stage of differentiation, according to the cancer stem cell hypothesis, confers to the tumor cells clinically important properties, such as resistance to therapies and seeding abilities.
Moreover, there is a current challenge in establishing whether the metastatic cells arise from the most aggressive and dominant clone in the primary tumor or the metastasic tissue diverges with substantial genetic changes very early in the evolution of the disease. Primary and metastatic tumor may have a close clonal relationship or evolve in parallel and acquire different genomic alterations. In the real life, it is plausible that both models coexist with different predominance according to the tumoral tissue and etiology.
The study hypothesizes that breast cancer metastases and primary tumors could harbor different genomic profiles related to genomic regions of interest in a clinically relevant proportion of metastatic breast cancer patients.
Moreover, the genomic aberrations found in the metastatic breast cancer tissue could also be detected in CTCs and circulating free DNA.
If true, CTCs and circulating free DNA would be convenient, non-invasive, easily accessible sources of genomic material for the analysis of mutations and other genomic aberrations.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with metastatic breast cancer in which FFPE samples from the primary tumors are available and in whom a biopsy of the metastatic relapse is clinically indicated. Investigators will offer enrollment to consecutively seen women who meet the entry criteria. Target enrollment is 40 patients
Key inclusion criteria (6 listed)
- Metastatic breast cancer confirmed by radiologic findings
- ≥ 18 years old
- Able to give signed consent
- Availability to get the paraffin block of her primary tumor.
- First metastatic relapse or tumor regrowth while on treatment for metastatic disease (progressive disease while on treatment)
Key exclusion criteria (6 listed)
- Inability to get a core sample from a metastatic site
- Bone disease only (the decalcification process usually prevents an appropriate genomic study).
- Unable to drawn peripheral blood
- Unable to give the informed consent
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cohen's kappa coefficient to measure the inter-rater agreement for mutations and other genomic findings (categorical items) between the metastatic tissue and the primary tumor tissue in Metastatic Breast Cancer patients.
Time frame: 26 months
2 secondary outcomes
Number of somatic genomic findings (found in the primary and metastatic tumor) in circulating tumoral cells (CTC) and circulating free DNA(cfDNA) obtained from peripheral blood (liquid biopsy).
Time frame: 26 months
Description of the mutations in analyzed genes in the primary tumor and in CTC/cfDNA for each patient.
Time frame: 26 months
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 11 Aug 2020.
- Derived from this study: PubMed 27531554Gonzalez-Rivera M, Picornell AC, Alvarez EL, Martin M. A Cross-Sectional Comparison of Druggable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells, and Cell-Free Circulating DNA in Patients with Metastatic Breast Cancer: The MIRROR Study Protocol. JMIR Res Protoc. 2016 Aug 16;5(3):e167. doi: 10.2196/resprot.6024.
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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.
Miguel Martín, Ph study chair
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 6 inclusion and 6 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Cohen's kappa coefficient to measure the inter-rater agreement for mutations and other genomic findings (categorical items) between the metastatic tissue and the primary tumor tissue in Metastatic Breast Cancer patients. (time frame: 26 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 NCT02626039, 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 11 Aug 2020.