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Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04021069
Enrollment
800
Registered
2019-07-16
Start date
2018-08-30
Completion date
2024-08-30
Last updated
2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma

Keywords

radiomics, pathomics, breast cancer, machine learning, biomarkers

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.

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.

Interventions

This is a non-interventional study.

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pathologic complete response (pCR)Up to 60 monthsEvaluating the degree of absence of residual cancer cells

Secondary

MeasureTime frameDescription
Time to local breast recurrenceUp to 60 monthsEvaluating the time until a recurrence event has occurred in the breast
Time to distant metastasis (months)Up to 60 monthsEvaluating onset of distant metastasis
Time to deathUp to 60 monthsEvaluating time to cancer-related death

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026