Breast Cancer Clinical Trial
Official title:
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Verified date | July 2019 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 800 |
Est. completion date | August 30, 2024 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic complete response (pCR) | Evaluating the degree of absence of residual cancer cells | Up to 60 months | |
Secondary | Time to local breast recurrence | Evaluating the time until a recurrence event has occurred in the breast | Up to 60 months | |
Secondary | Time to distant metastasis (months) | Evaluating onset of distant metastasis | Up to 60 months | |
Secondary | Time to death | Evaluating time to cancer-related death | Up to 60 months |
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