CompletedNot Applicable

Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Canada100 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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.

What they're measuring

Pathologic complete response (pCR)

Timeframe: Up to 60 months

Trial details

NCT IDNCT03709134

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Breast Cancer trials