Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Sunnybrook Health Sciences Centre

Status: Active, not recruiting

Conditions: Breast Cancer; Invasive Lobular Breast Carcinoma; Invasive Ductal Breast Carcinoma

Treatments: Diagnostic Test: Radiomic, pathomic, and clinical markers

Study type: Observational

Funder types: Other

Identifiers

NCT04021069

270-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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