Breast NeoplasmsNCT04241237
Concordance Between Liquid and Tissue Biopsy
An observational study of Breast Neoplasms, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2020to Dec 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study cohort will be selected from the Breast Cancer patients visiting London Regional Cancer Program for the treatment of their disease.
Who may be able to join
- Adult (≥18 years of age) diagnosed with primary breast cancer (BC) any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified
- Patients must have suspected recurrent metastatic BC that will be confirmed by tissue biopsy that is expected to yield tissue adequate for histologic examination (sampling expected to yield material for cytologic evaluation only does not satisfy this criterion)
- The suspected metastases must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI
Who cannot join
- Only locoregional recurrence (ipsilateral breast, axilla, infra/supraclavicular) suspected (see above regarding potential contralateral axillary or infra/supraclavicular metastases as only site of metastasis)
- Tissue biopsy occurs prior to blood collection for CTCs and ctDNA
- New treatment for suspected metastases commences prior to blood collection for CTCs and ctDNA
- Patient has received previous lines of systemic treatment for metastatic BC
- Previous history of an invasive non-BC apart from cancers treated with curative intent at least 5 years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
- Patients unable or unwilling to undergo a tissue biopsy
- Patients unable to provide informed consent
- Patients undergoing only cytologic evaluation of suspected metastases
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 5W9
Robin Sachdeva, PhD, 519-685-8500 ext. 54005, robin.sachdeva@lhsc.on.ca
Lucas Mendez, MD, PhD
About this study
Official title: Concordance Between Liquid and Tissue Biopsy in Newly Diagnosed Metastatic Breast Cancer
Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).
Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.
Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors \& HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.
Read the detailed description
In Canada, it is estimated that more than 26,900 women will be diagnosed with breast cancer (BC), and 5,000 women will die from BC in 2019. Metastatic BC will cause the vast majority of these deaths. Tissue biopsy is recommended to confirm recurrence (presence of cancer cells) in patients with a history of previous BC. Additionally, tissue biopsy provides information on BC subtypes (estrogen receptor (ER), progesterone receptor (PgR), and HER2 status). Technological advances over the last several years have led to more robust methods for the detection, quantification, and characterization of liquid biopsy (including CTCs and ctDNA) in recurrent BC. If these approaches demonstrate sufficiently concordant results to tissue-based testing, blood draws may quickly become a viable alternative to invasive biopsies.
In a cross-sectional study, 120 consecutive individuals from study centers in Ontario, who present with highly suspicious BC distant metastases who undergo biopsy to confirm BC recurrence will be enrolled (enrollment will be continued until 100 subjects with confirmed metastatic breast cancer have been enrolled). Blood samples for the circulating factors will be taken within 30 days prior to the tissue biopsy. Patient and tumor characteristics will be recorded. At the end of study, liquid biopsy (CTCs and ctDNA) analyses will be performed blinded to biopsy results. Investigators will continuously review the number of participants in each BC subtype. Cases with tissue biopsy results not classified as definite or highly suspicious for metastatic breast cancer by the treating physician will be re-assessed after six month of study entry in an attempt to classify them as having metastatic breast cancer or not. This aims to confirm/rule out breast cancer or other diagnosis.
The overall anticipated public and/or scientific benefit of the study is to demonstrate the concordance between liquid (blood) biopsy and tissue based tests in terms of the presence of cancer cells, hormone receptors, HER2 status etc. so these tests could be used in the future to confirm diagnosis using a non-invasive procedure. The results of this study will advance our understanding of liquid biomarkers and ideally improve the care journey for breast cancer patients by not subjecting them to invasive and potentially dangerous biopsy procedures.
- Conditions
- Breast Neoplasms
- Being tested
- Blood Draw
- Keywords
- Breast Cancer, Circulating Tumor Cells, Circulating Tumor DNA, Liquid Biopsy, Tissue biopsy, Concordance
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer patients | Investigators plan to enroll patients who are undergoing biopsy for potential metastatic Breast Cancer any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified. The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between liquid and tissue biopsy in terms of presence or absence of Cancer
To analyze concordance between liquid biopsy, CTCs (Epic Sciences) and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results
Measured: Its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Secondary outcomes (3)
Concordance between liquid and tissue biopsy in terms of hormone and HER2 status
To conduct secondary analyses of the concordance between hormone receptor and HER2 status identified on tissue specimens with those identified on CTCs (Epic Sciences).
Measured: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Classification of tissue biopsy results
To classify tissue biopsy results according to the interpretation of the local pathologist, the treating physician (primary comparator) and the study investigators (interpretations to include clinical data such as physical exam, radiologic investigations, blood work as available).
Measured: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Exploratory analysis
To conduct exploratory analyses of the associations between tumor markers and CTCs or ctDNA.
Measured: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jul 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Epic Sciences, University of Western Ontario, Canada, Lunenfeld Tanenbaum Research Institute, MOUNT SINAI HOSPITAL, Toronto Sunnybrook Regional Cancer Centre, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Ana Lohmann, MD, PhD, Principal investigator, London Regional Cancer Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241237
- Sponsor's protocol ID
- Concordance
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simmons C, Miller N, Geddie W, Gianfelice D, Oldfield M, Dranitsaris G, Clemons MJ. Does confirmatory tumor biopsy alter the management of breast cancer patients with distant metastases? Ann Oncol. 2009 Sep;20(9):1499-1504. doi: 10.1093/annonc/mdp028. Epub 2009 Mar 18.
PubMed 19299408Macfarlane R, Seal M, Speers C, Woods R, Masoudi H, Aparicio S, Chia SK. Molecular alterations between the primary breast cancer and the subsequent locoregional/metastatic tumor. Oncologist. 2012;17(2):172-8. doi: 10.1634/theoncologist.2011-0127. Epub 2012 Jan 20.
PubMed 22267852Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
PubMed 15317891Paoletti C, Muniz MC, Thomas DG, Griffith KA, Kidwell KM, Tokudome N, Brown ME, Aung K, Miller MC, Blossom DL, Schott AF, Henry NL, Rae JM, Connelly MC, Chianese DA, Hayes DF. Development of circulating tumor cell-endocrine therapy index in patients with hormone receptor-positive breast cancer. Clin Cancer Res. 2015 Jun 1;21(11):2487-98. doi: 10.1158/1078-0432.CCR-14-1913. Epub 2014 Nov 7.
PubMed 25381338Fujii T, Reuben JM, Huo L, Espinosa Fernandez JR, Gong Y, Krupa R, Suraneni MV, Graf RP, Lee J, Greene S, Rodriguez A, Dugan L, Louw J, Lim B, Barcenas CH, Marx AN, Tripathy D, Wang Y, Landers M, Dittamore R, Ueno NT. Androgen receptor expression on circulating tumor cells in metastatic breast cancer. PLoS One. 2017 Sep 28;12(9):e0185231. doi: 10.1371/journal.pone.0185231. eCollection 2017.
PubMed 28957377Scher HI, Graf RP, Schreiber NA, McLaughlin B, Lu D, Louw J, Danila DC, Dugan L, Johnson A, Heller G, Fleisher M, Dittamore R. Nuclear-specific AR-V7 Protein Localization is Necessary to Guide Treatment Selection in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Jun;71(6):874-882. doi: 10.1016/j.eururo.2016.11.024. Epub 2016 Dec 12.
PubMed 27979426Meng S, Tripathy D, Frenkel EP, Shete S, Naftalis EZ, Huth JF, Beitsch PD, Leitch M, Hoover S, Euhus D, Haley B, Morrison L, Fleming TP, Herlyn D, Terstappen LW, Fehm T, Tucker TF, Lane N, Wang J, Uhr JW. Circulating tumor cells in patients with breast cancer dormancy. Clin Cancer Res. 2004 Dec 15;10(24):8152-62. doi: 10.1158/1078-0432.CCR-04-1110.
PubMed 15623589Janni WJ, Rack B, Terstappen LW, Pierga JY, Taran FA, Fehm T, Hall C, de Groot MR, Bidard FC, Friedl TW, Fasching PA, Brucker SY, Pantel K, Lucci A. Pooled Analysis of the Prognostic Relevance of Circulating Tumor Cells in Primary Breast Cancer. Clin Cancer Res. 2016 May 15;22(10):2583-93. doi: 10.1158/1078-0432.CCR-15-1603. Epub 2016 Jan 5.
PubMed 26733614Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
PubMed 30992300Bratman SV, Newman AM, Alizadeh AA, Diehn M. Potential clinical utility of ultrasensitive circulating tumor DNA detection with CAPP-Seq. Expert Rev Mol Diagn. 2015 Jun;15(6):715-9. doi: 10.1586/14737159.2015.1019476. Epub 2015 Mar 16.
PubMed 25773944Newman AM, Lovejoy AF, Klass DM, Kurtz DM, Chabon JJ, Scherer F, Stehr H, Liu CL, Bratman SV, Say C, Zhou L, Carter JN, West RB, Sledge GW, Shrager JB, Loo BW Jr, Neal JW, Wakelee HA, Diehn M, Alizadeh AA. Integrated digital error suppression for improved detection of circulating tumor DNA. Nat Biotechnol. 2016 May;34(5):547-555. doi: 10.1038/nbt.3520. Epub 2016 Mar 28.
PubMed 27018799Visvanathan K, Fackler MS, Zhang Z, Lopez-Bujanda ZA, Jeter SC, Sokoll LJ, Garrett-Mayer E, Cope LM, Umbricht CB, Euhus DM, Forero A, Storniolo AM, Nanda R, Lin NU, Carey LA, Ingle JN, Sukumar S, Wolff AC. Monitoring of Serum DNA Methylation as an Early Independent Marker of Response and Survival in Metastatic Breast Cancer: TBCRC 005 Prospective Biomarker Study. J Clin Oncol. 2017 Mar;35(7):751-758. doi: 10.1200/JCO.2015.66.2080. Epub 2016 Nov 21.
PubMed 27870562Shen SY, Singhania R, Fehringer G, Chakravarthy A, Roehrl MHA, Chadwick D, Zuzarte PC, Borgida A, Wang TT, Li T, Kis O, Zhao Z, Spreafico A, Medina TDS, Wang Y, Roulois D, Ettayebi I, Chen Z, Chow S, Murphy T, Arruda A, O'Kane GM, Liu J, Mansour M, McPherson JD, O'Brien C, Leighl N, Bedard PL, Fleshner N, Liu G, Minden MD, Gallinger S, Goldenberg A, Pugh TJ, Hoffman MM, Bratman SV, Hung RJ, De Carvalho DD. Sensitive tumour detection and classification using plasma cell-free DNA methylomes. Nature. 2018 Nov;563(7732):579-583. doi: 10.1038/s41586-018-0703-0. Epub 2018 Nov 14.
PubMed 30429608Shen SY, Burgener JM, Bratman SV, De Carvalho DD. Preparation of cfMeDIP-seq libraries for methylome profiling of plasma cell-free DNA. Nat Protoc. 2019 Oct;14(10):2749-2780. doi: 10.1038/s41596-019-0202-2. Epub 2019 Aug 30.
PubMed 31471598Gion M, Peloso L, Mione R, Vignati G, Fortunato A, Saracchini S, Biasioli R, Gulisano M, Cappelli G. Tumor markers in breast cancer monitoring should be scheduled according to initial stage and follow-up time: a prospective study on 859 patients. Cancer J. 2001 May-Jun;7(3):181-90.
PubMed 11419026
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Liquid and Tissue Biopsy in Newly Diagnosed Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04241237
- Acronym / sponsor ID
- Concordance
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Circulating Tumor Cells, Circulating Tumor DNA, Liquid Biopsy, Tissue biopsy, Concordance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Epic Sciences, University of Western Ontario, Canada, Lunenfeld Tanenbaum Research Institute, MOUNT SINAI HOSPITAL, Toronto Sunnybrook Regional Cancer Centre, University of Toronto
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- 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.
Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).
Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.
Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors \& HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.
Detailed description
In Canada, it is estimated that more than 26,900 women will be diagnosed with breast cancer (BC), and 5,000 women will die from BC in 2019. Metastatic BC will cause the vast majority of these deaths. Tissue biopsy is recommended to confirm recurrence (presence of cancer cells) in patients with a history of previous BC. Additionally, tissue biopsy provides information on BC subtypes (estrogen receptor (ER), progesterone receptor (PgR), and HER2 status). Technological advances over the last several years have led to more robust methods for the detection, quantification, and characterization of liquid biopsy (including CTCs and ctDNA) in recurrent BC. If these approaches demonstrate sufficiently concordant results to tissue-based testing, blood draws may quickly become a viable alternative to invasive biopsies.
In a cross-sectional study, 120 consecutive individuals from study centers in Ontario, who present with highly suspicious BC distant metastases who undergo biopsy to confirm BC recurrence will be enrolled (enrollment will be continued until 100 subjects with confirmed metastatic breast cancer have been enrolled). Blood samples for the circulating factors will be taken within 30 days prior to the tissue biopsy. Patient and tumor characteristics will be recorded. At the end of study, liquid biopsy (CTCs and ctDNA) analyses will be performed blinded to biopsy results. Investigators will continuously review the number of participants in each BC subtype. Cases with tissue biopsy results not classified as definite or highly suspicious for metastatic breast cancer by the treating physician will be re-assessed after six month of study entry in an attempt to classify them as having metastatic breast cancer or not. This aims to confirm/rule out breast cancer or other diagnosis.
The overall anticipated public and/or scientific benefit of the study is to demonstrate the concordance between liquid (blood) biopsy and tissue based tests in terms of the presence of cancer cells, hormone receptors, HER2 status etc. so these tests could be used in the future to confirm diagnosis using a non-invasive procedure. The results of this study will advance our understanding of liquid biomarkers and ideally improve the care journey for breast cancer patients by not subjecting them to invasive and potentially dangerous biopsy procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer patients | – | Procedure: Blood DrawInvestigators plan to enroll patients who are undergoing biopsy for potential metastatic Breast Cancer any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified. The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study cohort will be selected from the Breast Cancer patients visiting London Regional Cancer Program for the treatment of their disease.
Key inclusion criteria (3 listed)
- Adult (≥18 years of age) diagnosed with primary breast cancer (BC) any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified
- Patients must have suspected recurrent metastatic BC that will be confirmed by tissue biopsy that is expected to yield tissue adequate for histologic examination (sampling expected to yield material for cytologic evaluation only does not satisfy this criterion)
- The suspected metastases must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI
Key exclusion criteria (8 listed)
- Only locoregional recurrence (ipsilateral breast, axilla, infra/supraclavicular) suspected (see above regarding potential contralateral axillary or infra/supraclavicular metastases as only site of metastasis)
- Tissue biopsy occurs prior to blood collection for CTCs and ctDNA
- New treatment for suspected metastases commences prior to blood collection for CTCs and ctDNA
- Patient has received previous lines of systemic treatment for metastatic BC
- Previous history of an invasive non-BC apart from cancers treated with curative intent at least 5 years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
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 |
|---|---|---|
| Blood DrawBlood will be drawn from each patient to check the concordance between liquid and tissue biopsy | Procedure or surgery | Metastatic Breast Cancer patients |
Primary outcome
Concordance between liquid and tissue biopsy in terms of presence or absence of Cancer
Time frame: Its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
To analyze concordance between liquid biopsy, CTCs (Epic Sciences) and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results
3 secondary outcomes
Concordance between liquid and tissue biopsy in terms of hormone and HER2 status
Time frame: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Classification of tissue biopsy results
Time frame: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Exploratory analysis
Time frame: Its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Results publication: PubMed 19299408Simmons C, Miller N, Geddie W, Gianfelice D, Oldfield M, Dranitsaris G, Clemons MJ. Does confirmatory tumor biopsy alter the management of breast cancer patients with distant metastases? Ann Oncol. 2009 Sep;20(9):1499-1504. doi: 10.1093/annonc/mdp028. Epub 2009 Mar 18.
- Results publication: PubMed 22267852Macfarlane R, Seal M, Speers C, Woods R, Masoudi H, Aparicio S, Chia SK. Molecular alterations between the primary breast cancer and the subsequent locoregional/metastatic tumor. Oncologist. 2012;17(2):172-8. doi: 10.1634/theoncologist.2011-0127. Epub 2012 Jan 20.
- Results publication: PubMed 15317891Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
- Results publication: PubMed 25381338Paoletti C, Muniz MC, Thomas DG, Griffith KA, Kidwell KM, Tokudome N, Brown ME, Aung K, Miller MC, Blossom DL, Schott AF, Henry NL, Rae JM, Connelly MC, Chianese DA, Hayes DF. Development of circulating tumor cell-endocrine therapy index in patients with hormone receptor-positive breast cancer. Clin Cancer Res. 2015 Jun 1;21(11):2487-98. doi: 10.1158/1078-0432.CCR-14-1913. Epub 2014 Nov 7.
- Results publication: PubMed 28957377Fujii T, Reuben JM, Huo L, Espinosa Fernandez JR, Gong Y, Krupa R, Suraneni MV, Graf RP, Lee J, Greene S, Rodriguez A, Dugan L, Louw J, Lim B, Barcenas CH, Marx AN, Tripathy D, Wang Y, Landers M, Dittamore R, Ueno NT. Androgen receptor expression on circulating tumor cells in metastatic breast cancer. PLoS One. 2017 Sep 28;12(9):e0185231. doi: 10.1371/journal.pone.0185231. eCollection 2017.
- Results publication: PubMed 27979426Scher HI, Graf RP, Schreiber NA, McLaughlin B, Lu D, Louw J, Danila DC, Dugan L, Johnson A, Heller G, Fleisher M, Dittamore R. Nuclear-specific AR-V7 Protein Localization is Necessary to Guide Treatment Selection in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Jun;71(6):874-882. doi: 10.1016/j.eururo.2016.11.024. Epub 2016 Dec 12.
- Results publication: PubMed 15623589Meng S, Tripathy D, Frenkel EP, Shete S, Naftalis EZ, Huth JF, Beitsch PD, Leitch M, Hoover S, Euhus D, Haley B, Morrison L, Fleming TP, Herlyn D, Terstappen LW, Fehm T, Tucker TF, Lane N, Wang J, Uhr JW. Circulating tumor cells in patients with breast cancer dormancy. Clin Cancer Res. 2004 Dec 15;10(24):8152-62. doi: 10.1158/1078-0432.CCR-04-1110.
- Results publication: PubMed 26733614Janni WJ, Rack B, Terstappen LW, Pierga JY, Taran FA, Fehm T, Hall C, de Groot MR, Bidard FC, Friedl TW, Fasching PA, Brucker SY, Pantel K, Lucci A. Pooled Analysis of the Prognostic Relevance of Circulating Tumor Cells in Primary Breast Cancer. Clin Cancer Res. 2016 May 15;22(10):2583-93. doi: 10.1158/1078-0432.CCR-15-1603. Epub 2016 Jan 5.
- Results publication: PubMed 30992300Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
- Results publication: PubMed 25773944Bratman SV, Newman AM, Alizadeh AA, Diehn M. Potential clinical utility of ultrasensitive circulating tumor DNA detection with CAPP-Seq. Expert Rev Mol Diagn. 2015 Jun;15(6):715-9. doi: 10.1586/14737159.2015.1019476. Epub 2015 Mar 16.
- Results publication: PubMed 27018799Newman AM, Lovejoy AF, Klass DM, Kurtz DM, Chabon JJ, Scherer F, Stehr H, Liu CL, Bratman SV, Say C, Zhou L, Carter JN, West RB, Sledge GW, Shrager JB, Loo BW Jr, Neal JW, Wakelee HA, Diehn M, Alizadeh AA. Integrated digital error suppression for improved detection of circulating tumor DNA. Nat Biotechnol. 2016 May;34(5):547-555. doi: 10.1038/nbt.3520. Epub 2016 Mar 28.
- Results publication: PubMed 27870562Visvanathan K, Fackler MS, Zhang Z, Lopez-Bujanda ZA, Jeter SC, Sokoll LJ, Garrett-Mayer E, Cope LM, Umbricht CB, Euhus DM, Forero A, Storniolo AM, Nanda R, Lin NU, Carey LA, Ingle JN, Sukumar S, Wolff AC. Monitoring of Serum DNA Methylation as an Early Independent Marker of Response and Survival in Metastatic Breast Cancer: TBCRC 005 Prospective Biomarker Study. J Clin Oncol. 2017 Mar;35(7):751-758. doi: 10.1200/JCO.2015.66.2080. Epub 2016 Nov 21.
- 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.
Ana Lohmann, MD, PhD principal investigator
London Regional Cancer Program
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 Breast Neoplasms, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin Sachdeva, PhD (519-685-8500 ext. 54005, robin.sachdeva@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between liquid and tissue biopsy in terms of presence or absence of Cancer (time frame: Its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.). 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 NCT04241237, which also lists 16 linked publications.
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 2 Sep 2021.