Viewing Study NCT04038489



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Last Modification Date: 2024-10-26 @ 1:15 PM
Study NCT ID: NCT04038489
Status: WITHDRAWN
Last Update Posted: 2021-11-22
First Post: 2019-07-10

Brief Title: COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER HER2- Stage I-III Breast Cancer
Sponsor: University of Virginia
Organization: University of Virginia

Study Overview

Official Title: COX Inhibition and Biomarkers of Response During Neoadjuvant Chemoendocrine Therapy for Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Stage I-III Breast Cancer
Status: WITHDRAWN
Status Verified Date: 2021-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Lack of accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Breast 51
Brief Summary: This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor aspirin given in combination with standard AC-T chemotherapy doxorubicin cyclophosphamide and paclitaxel for the treatment of high-risk estrogen receptor ER human epidermal growth factor receptor 2 HER2- breast cancer If successful the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ERHER2- breast cancer
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None