Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy

Completed

• Conditions: Breast Neoplasms; Cancer, Breast; Breast Cancer

• Registration Number: 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 Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2019-10-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response (pCR)	Up to 60 months	Evaluating the degree of absence of residual cancer cells

Secondary Outcome Measures

Name	Time	Method
Time to distant breast cancer recurrence (months)	Up to 60 months	Evaluating the time until a recurrence event has occurred in the breast.
Time to any recurrence (months)	Up to 60 months	Evaluating the time until a local, regional, or distant recurrence event has occurred.
Time to death	Up to 60 months	Evaluating time to cancer-related death

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada