NCT04021069

Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Invasive Ductal Breast Carcinoma
• Invasive Lobular Breast Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Radiomic, pathomic, and clinical markers	This is a non-interventional study.

Timeline

• Start date: 2018-08-30
• Primary completion: 2019-12-30
• Completion: 2024-08-30
• First posted: 2019-07-16
• Last updated: 2019-07-16

Locations

1 site across 1 country: Canada