Breast Cancer Clinical Trial
Official title:
Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT
NCT number | NCT04962529 |
Other study ID # | PCS-001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 28, 2020 |
Est. completion date | July 31, 2023 |
The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | July 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Arm 1 Inclusion criteria: - All subjects must be capable of providing informed consent - Subjects (= 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. o Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment - Subjects must have suspected recurrent metastatic BC or MBC with clinical signs of progression that will be confirmed/evaluated by tissue biopsy that is expected to yield tissue adequate for histologic examination. Note that patients presenting with de novo metastasis are eligible provided a tissue biopsy meets the above criteria. - Tissue biopsy of a suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study. - The suspected metastases biopsied may be from any lesion outside the ipsilateral breast and 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 imaging. - No history of any other cancers (except for non-melanoma skin cancer) - Ability to access 3-month outcome data (de-identified, consented patients included for second draw at 3-month timepoint or within 14 days for the first post-treatment imaging, whichever comes first). - Data from contemporaneous diagnosis (metastatic recurrence or de novo) and in applicable past diagnosis (primary) must be accessible, including a pathology report that details standard markers and morphology describing how malignancy/cancer of origin was determined. Arm 1 Exclusion Criteria: - Unable to provide informed consent - New treatment commences prior to liquid biopsy blood collection - Previous history of an invasive non-breast cancer (except for non-melanoma skin cancer) - Subjects not undergoing a tissue biopsy at time of blood draw (for suspected breast cancer recurrence or prior to beginning new line of metastatic treatment) - Subjects with only a new contralateral breast primary tumor Arm 2 Inclusion criteria: - Capable of providing informed consent - Subjects (= 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. - Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment - The suspected metastasis biopsied may be from any lesion outside the ipsilateral breast and 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 imaging. - Confirmation of progression of MBC must be confirmed by imaging - (Optional) Tissue biopsy of suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study. - No history of any other cancers (except for non-melanoma skin cancer) - Data from primary BCa diagnosis must be accessible, including detailed description with standard markers and morphology describing how malignancy/cancer of origin was determined. - Subject must exhibit clinical signs of breast cancer recurrence or progression of previously confirmed metastatic breast cancer Arm 2 Exclusion Criteria: - Subjects unable to provide informed consent - New treatment regimen commences prior to liquid biopsy blood collection - Subjects on treatment for MBC with no imaging evidence of clinical progression - Previous history of an invasive non-BC apart from cancers treated with curative intent at least five (5) years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer |
Country | Name | City | State |
---|---|---|---|
Canada | Saskatoon City Hospital | Saskatoon | Saskatchewan |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | Montefiore Medical Center | Bronx | New York |
United States | Miami Memorial Healthcare System | Hollywood | Florida |
United States | New York Cancer & Blood Specialists | New York | New York |
United States | Ocala Oncology | Ocala | Florida |
United States | 6555 Sanger Rd, Suite 260 | Orlando | Florida |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Anthony Magliocco | DHR Health Institute for Research and Development, Epic Sciences, Florida Cancer Specialist, Memorial Healthcare System, Montefiore Medical Center, Northwest Community Healthcare, NY Health d/b/a New York Cancer and Blood Specialists, Ocala Oncology, University of Saskatchewan |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance between liquid and tissue biopsy in terms of presence or absence of cancer | To analyze concordance between liquid biopsy, Circulating tumor (ct) cells 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 | Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy | |
Secondary | Classification of tissue biopsy | After confirmation of tumor area and cellularity, slides will be stained with the appropriate Immunohisto Chemistry: Progesterone Receptor (clone 1E2), Estrogen Receptor (clone SP1), GATA3, TTF1, PD-L1 (SP142), FOXA1, or HER2 (4B5). | Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy | |
Secondary | Exploratory analysis | Exploratory analyses will include agreement of GATA3, FOXA1 and PDL1 staining results between liquid and tissue biopsies, where possible. | Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy | |
Secondary | Concordance between liquid and tissue biopsy in terms of hormone and HER2 status | Secondary analysis of the concordance between hormone receptor and HER status identified on tissue with identified CTCs | Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy | |
Secondary | Physician Feedback for Test Experience Improvements | To provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements | Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy |
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