Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

NCT ID: NCT04021069

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-30

Study Completion Date

2024-08-30

Brief Summary

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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

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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

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Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiomic, pathomic, and clinical markers

This is a non-interventional study.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. William Tran

Radiation Therapist Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William T. Tran, MRT(T), PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Kasia Jerzak, M.Sc., MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Fang-I Lu, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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270-2018

Identifier Type: -

Identifier Source: org_study_id

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