Recruiting

Biopsy Concordance

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04241237

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

Brief 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. 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.

Conditions

Breast Neoplasms

Study ID

NCT04241237

Start date

Jul 1, 2020

Status verified date

Aug, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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: Its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy. ]

Central Contacts and Locations

Central contacts

Robin Sachdeva, PhD

519-685-8500robin.sachdeva@lhsc.on.ca

Locations

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Robin Sachdeva, PhD

519-685-8500robin.sachdeva@lhsc.on.ca

Principal Investigator:

Lucas Mendez, MD, PhD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Sep 2, 2021

Last verified

Aug, 2021

Keywords

  • Breast Cancer
  • Circulating Tumor Cells
  • Circulating Tumor DNA
  • Liquid Biopsy
  • Tissue biopsy
  • Concordance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2021-09-02.