Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Breast Cancer Clinical Trial

Official title:

Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03709134
• Other study ID #: 178-2018
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer, Breast

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