CompletedNCT03709134Updated Jan 20, 2025

Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

An observational study in Breast Cancer, Breast Neoplasms and Cancer, Breast, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by Sunnybrook Health Sciences Centre · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 100
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the 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.

Conditions studied

Breast Cancer
Breast Neoplasms
Cancer, Breast

Browse trials for

Breast Neoplasms 12,544

Keywords

Circulating tumor cells
CTC
Circulating tumor DNA
ctDNA
Genomics
Transcriptomics

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 100 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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.

Inclusion criteria

Subjects must give appropriate written informed consent prior to participation in the study.
Subjects must be women or men age 18+.
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).
Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
Stage I-III disease according to the AJCC v7 criteria.

Exclusion criteria

Exclusion Criteria:

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.
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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 100 participants (actual)
Target follow-up: 5 Years
Patient registry: Yes
Biospecimen retention: Samples with dna

Interventions

Diagnostic testGenomic Markers (CTC/ctDNA)
This is a non-interventional study.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03709134
Lead sponsor: Sunnybrook Health Sciences Centre
Responsible party: Dr. Katarzyna Jerzak (Medical Oncologist & Associate Scientist, Sunnybrook Health Sciences Centre) — Principal investigator
First posted: Oct 17, 2018
Start date: Oct 1, 2019
Primary completion: Sep 1, 2022
Completion: Sep 1, 2022
Last update: Jan 20, 2025

Study contacts

Katarzyna J Jerzak, MD, MSc, FRCPC

principal investigator · Sunnybrook Health Sciences Centre

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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