Official Title
Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Brief Title
Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Protocol ID
NCT03709134
Lead Sponsor
Sunnybrook Health Sciences Centre
Brief 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.
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 Period
-
Enrollment Count
100 participants
Eligibility Criteria
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.
Filters
Breast Cancer
Breast Neoplasms
Cancer, Breast
COMPLETED
ADULT
OLDER_ADULT