Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Invasive Lobular Breast Carcinoma; Invasive Ductal Breast Carcinoma
• Intervention / Treatment: Diagnostic test: Radiomic, pathomic, and clinical markers

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 Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer of any stage, according to the AJCC v7 criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete response (pCR)	Evaluating the degree of absence of residual cancer cells	Up to 60 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: William T. Tran, MRT(T), PhD, Sunnybrook Health Sciences Centre; Principal Investigator: Kasia Jerzak, M.Sc., MD, Sunnybrook Health Sciences Centre; Principal Investigator: Fang-I Lu, MD, FRCPC, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2018
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): August 30, 2024

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; machine learning; biomarkers; radiomics; pathomics
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Breast Neoplasms; Carcinoma; Carcinoma, Lobular; Carcinoma, Ductal, Breast
• Other Study ID Numbers: 270-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be anonymized. Digital pathology images and anonymized clinical data will be deposited into the National Cancer Institute (NCI) data sharing repository, including The Cancer Imaging Archive (TCIA). Digital pathology images will also be annotated to facilitate analysis for other investigators. Computational methods, source-codes and instructions will be deposited to the open-source coding repository, GitHub (www.github.com).
• IPD Sharing Time Frame: Data will be available within 12 months of study completion.
• IPD Sharing Access Criteria: Digital pathology images, anonymized clinical data, source codes, and computational methods will be deposited to open-source repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No