Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

NCT04021069 — Unknown, 800 participants, Sunnybrook Health Sciences Centre

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Registry	NCT04021069
Status	Unknown
Study type	Observational
Enrollment	800 (Actual)
Sponsor	Sunnybrook Health Sciences Centre (Other)
Conditions	Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma
Interventions	Radiomic, pathomic, and clinical markers (Diagnostic test)
Dates	start 2018-08-30, primary completion 2019-12-30 (estimated), completion 2024-08-30 (estimated), first posted 2019-07-16, last updated 2019-07-16
Locations	1 site in Canada

-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.

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+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.

+Arms and interventions

Radiomic, pathomic, and clinical markers (Diagnostic test): This is a non-interventional study.

+Outcome measures

Primary outcomes

Pathologic complete response (pCR) [Up to 60 months]: Evaluating the degree of absence of residual cancer cells

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Sunnybrook Health Sciences Centre	Toronto, Ontario	Canada

+Investigators

William T. Tran, MRT(T), PhD, Principal investigator, Sunnybrook Health Sciences Centre
Kasia Jerzak, M.Sc., MD, Principal investigator, Sunnybrook Health Sciences Centre
Fang-I Lu, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre