Recruiting

Liquid Biopsy

Sponsor:

Anthony Magliocco

Code:

NCT04962529

Conditions

Breast Cancer

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

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.

Conditions

Breast Cancer

Cancer

Study ID

NCT04962529

Start date

Sep 28, 2020

Status verified date

Aug, 2022

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Blood Draw

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

Primary outcome measure

  • Concordance between liquid and tissue biopsy in terms of presence or absence of cancer [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Hannah Park, BS

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

Joseph M Viscomi, BS

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

Locations

Miami Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Jayme Ion

jion@mhs.net

Nithya Sundararaman

9542651846NSundararaman@mhs.net

Principal Investigator:

Delia C Guaqueta Segura, MD

Ocala Oncology

Recruiting

Ocala, Florida, United States, 34474

Contacts

Sanjit Nirmandalahan, PhD

352-547-1958Sanjit.Nirmalanandhan@usoncology.com

Darcy Benedetto

(352) 547-1905darcy.benedetto@usoncology.com

Principal Investigator:

Rama Balaraman, MD

6555 Sanger Rd, Suite 260

Recruiting

Orlando, Florida, United States, 32827

Contacts

Hannah Park, BS

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

Joseph M Viscomi, BS

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

Principal Investigator:

Anthony Magliocco, MD

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Jon-Michael Eckert

941-917-4797jon-michael-eckert@smh.com

Principal Investigator:

Russell Novak, MD

Northwest Community Hospital

Recruiting

Arlington Heights, Illinois, United States, 60005

Contacts

Laura Lozano

847-618-4358llozano@nch.org

Karen Zwicky, MS

8476184386kzwicky@nch.org

Principal Investigator:

Marina Messinger, MD

Montefiore Medical Center

Recruiting

Bronx, New York, United States, 10467

Contacts

Prena Etchen

pzagreda@montefiore.org

Benjamin Duva

benjamin.duva@einsteinmed.edu

Principal Investigator:

Jesus D Anampa Mesias, MD

New York Cancer & Blood Specialists

Recruiting

New York, New York, United States, 10028

Contacts

Laura Brady

lbrady@nycancer.com

Joseph Battelli

jbattelli@nycancer.com

Principal Investigator:

Richard Zuniga, MD

Saskatoon City Hospital

Recruiting

Saskatoon, Saskatchewan, Canada

Contacts

Rashmi Nagaraj, MSc

rashmi.nagaraj@usask.ca

Andreea Badea

andreea.badea@usask.ca

Principal Investigator:

Gary Groot, MD

More Information

Sponsor

Anthony Magliocco

Last update posted

Aug 11, 2022

Last verified

Aug, 2022

Keywords

  • Recurrence
  • Metastatic Breast Cancer
  • Liquid Biopsy
  • Protean BioDiagnostics
  • Blood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Anthony Magliocco on 2022-08-11.