NCT04962529

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

December 17, 2020

Last Update Submit

August 8, 2022

Conditions

Breast CancerCancer

Keywords

RecurrenceMetastatic Breast CancerLiquid BiopsyProtean BioDiagnosticsBlood

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Classification of tissue biopsy

    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

  • Exploratory analysis

    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

  • Concordance between liquid and tissue biopsy in terms of hormone and HER2 status

    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

  • 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

Study Arms (2)

Arm 1: Metastatic Breast Cancer Patients With Contemporaneous Tissue Biopsy

Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis 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 or MRI If a tissue biopsy is performed, the matched tissue will be sent to the central pathology lab for reanalysis. If a tissue biopsy was performed, but the tissue block is exhausted or unavailable, patients are still eligible to participate in the study.

Procedure: Blood Draw

Arm 2: Metastatic Breast Cancer Patients Without Contemporaneous Tissue Biopsy

Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis 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 or MRI. A contemporaneous tissue biopsy is optional for this cohort.

Procedure: Blood Draw

Interventions

Blood DrawPROCEDURE

Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy

Arm 1: Metastatic Breast Cancer Patients With Contemporaneous Tissue BiopsyArm 2: Metastatic Breast Cancer Patients Without Contemporaneous Tissue Biopsy

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study cohort will be selected from the Breast Cancer patients visiting enrolled sites for the treatment of their disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Miami Memorial Healthcare System

Hollywood, Florida, 33021, United States

RECRUITING

Ocala Oncology

Ocala, Florida, 34474, United States

RECRUITING

6555 Sanger Rd, Suite 260

Orlando, Florida, 32827, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

RECRUITING

New York Cancer & Blood Specialists

New York, New York, 10028, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and FFPE tissue

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsRecurrence

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anthony Magliocco, MD

    CEO and Founder

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Park, BS

CONTACT

(754) 241-4209hannah.park@proteanbiodx.com

Joseph M Viscomi, BS

CONTACT

(754) 946-4309joseph.viscomi@proteanbiodx.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2020

First Posted

July 15, 2021

Study Start

September 28, 2020

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(1)