Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

January 17, 2025 updated by: Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre
The primary aim of the study is to identify genomic markers (circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (NAC) among patients with invasive breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to evaluate genetic markers (i.e. CTCs and ctDNA) in breast tumors to predict therapy response and metastatic risk. We aim to investigate genomic markers of treatment response and outcomes in breast cancer patients treated with neoadjuvant chemotherapy. The role of CTCs and ctDNA in predicting response to NAC will also be investigated.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer that is stage I-III according to the AJCC v7 criteria.

Description

Inclusion Criteria:

  1. Subjects must give appropriate written informed consent prior to participation in the study.
  2. Subjects must be women or men age 18+.
  3. Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist).
  4. Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
  5. Stage I-III disease according to the AJCC v7 criteria.

Exclusion Criteria:

  1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue.
  2. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete response (pCR)
Time Frame: Up to 60 months
Evaluating the degree of absence of residual cancer cells
Up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to death
Time Frame: Up to 60 months
Evaluating time to cancer-related death
Up to 60 months
Time to distant breast cancer recurrence (months)
Time Frame: Up to 60 months
Evaluating the time until a recurrence event has occurred in the breast.
Up to 60 months
Time to any recurrence (months)
Time Frame: Up to 60 months
Evaluating the time until a local, regional, or distant recurrence event has occurred.
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Katarzyna J Jerzak, MD, MSc, FRCPC, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 178-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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