Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

NCT03709134 | Completed

• 1 other identifier: 178-2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Cancer, Breast

Keywords

Circulating tumor cells; CTC; Circulating tumor DNA; ctDNA; Genomics; Transcriptomics

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR)

  Evaluating the degree of absence of residual cancer cells

  Up to 60 months

Secondary Outcomes (3)

• Time to distant breast cancer recurrence (months)

  Up to 60 months

• Time to any recurrence (months)

  Up to 60 months

• Time to death

  Up to 60 months

Interventions

Genomic Markers (CTC/ctDNA) DIAGNOSTIC_TEST

This is a non-interventional study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarzyna J Jerzak, MD, MSc, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist & Associate Scientist

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: October 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CA (1)