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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03709134
Other study ID # 178-2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date September 1, 2022

Study information

Verified date October 2021
Source Sunnybrook Health Sciences Centre
Contact Katarzyna J Jerzak, MD, MSc, FRCPC
Phone 416-480-6100
Email katarzyna.jerzak@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Genomic Markers (CTC/ctDNA)
This is a non-interventional study.

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathologic complete response (pCR) Evaluating the degree of absence of residual cancer cells Up to 60 months
Secondary Time to distant breast cancer recurrence (months) Evaluating the time until a recurrence event has occurred in the breast. Up to 60 months
Secondary Time to any recurrence (months) Evaluating the time until a local, regional, or distant recurrence event has occurred. Up to 60 months
Secondary Time to death Evaluating time to cancer-related death Up to 60 months
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