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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
Sponsor:
Information provided by (Responsible Party):
Dr. William Tran, 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.

Condition or disease Intervention/treatment
Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma 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.

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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Diagnostic Test: Radiomic, pathomic, and clinical markers
    This is a non-interventional study.


Primary Outcome Measures :
  1. Pathologic complete response (pCR) [ Time Frame: Up to 60 months ]
    Evaluating the degree of absence of residual cancer cells


Secondary Outcome Measures :
  1. Time to local breast recurrence [ Time Frame: Up to 60 months ]
    Evaluating the time until a recurrence event has occurred in the breast

  2. Time to distant metastasis (months) [ Time Frame: Up to 60 months ]
    Evaluating onset of distant metastasis

  3. Time to death [ Time Frame: Up to 60 months ]
    Evaluating time to cancer-related death


Biospecimen Retention:   Samples Without DNA
Fixed tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021069


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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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

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Responsible Party: Dr. William Tran, Radiation Therapist Clinician Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04021069     History of Changes
Other Study ID Numbers: 270-2018
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Time Frame: Data will be available within 12 months of study completion.
Access Criteria: 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: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. William Tran, Sunnybrook Health Sciences Centre:
radiomics
pathomics
breast cancer
machine learning
biomarkers

Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary