Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Pathologic complete response (pCR)
- Last Updated
- 6 years ago
Overview
Brief Summary
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.
Detailed Description
The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.
Investigators
Dr. William Tran
Radiation Therapist Clinician Scientist
Sunnybrook Health Sciences Centre
Eligibility Criteria
Inclusion Criteria
- •Participants must be men and women age 18+
- •Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
- •Any state of disease as described by AJCC v7 criteria
- •Participants must have received and completed neoadjuvant chemotherapy
Exclusion Criteria
- •Participants who had other primary cancers prior to breast cancer
Outcomes
Primary Outcomes
Pathologic complete response (pCR)
Time Frame: Up to 60 months
Evaluating the degree of absence of residual cancer cells
Secondary Outcomes
- Time to local breast recurrence(Up to 60 months)
- Time to distant metastasis (months)(Up to 60 months)
- Time to death(Up to 60 months)