Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

• Conditions: Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Carcinoma

• Registration Number: NCT04021069
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study Start: 2018-08-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-12
• Last Update Submitted: 2019-07-12
• Study First Posted: 2019-07-16
• Last Update Posted: 2019-07-16
• Primary Completion: 2019-12-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

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 local breast recurrence	Up to 60 months	Evaluating the time until a recurrence event has occurred in the breast
Time to distant metastasis (months)	Up to 60 months	Evaluating onset of distant metastasis
Time to death	Up to 60 months	Evaluating time to cancer-related death

Trial Locations

Locations (1)

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