Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
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ClinicalTrials.gov Identifier: NCT04021069
Recruitment Status :
Active, not recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. William Tran, Sunnybrook Health Sciences Centre
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.
Condition or disease
Breast CancerInvasive Ductal Breast CarcinomaInvasive Lobular Breast Carcinoma
Diagnostic Test: Radiomic, pathomic, and clinical markers
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
Participants who had other primary cancers prior to breast cancer
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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).
Data will be available within 12 months of study completion.
Digital pathology images, anonymized clinical data, source codes, and computational methods will be deposited to open-source repositories.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Dr. William Tran, Sunnybrook Health Sciences Centre:
Additional relevant MeSH terms:
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Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary