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COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer

NCT04038489 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-22

No results posted yet for this study

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 ER+/HER2- breast cancer.

Conditions

Interventions

DRUG

Aspirin

325 mg aspirin daily during AC-T chemotherapy

DRUG

Tamoxifen Pill

Tamoxifen (either 20 mg daily or 10 mg twice a day) during AC-T chemotherapy

DRUG

Doxorubicin

Doxorubicin (60 mg/m2) Given by IV with cyclophosphamide

DRUG

Cyclophosphamide

Cyclophosphamide (600 mg/m2) Given by IV with doxorubicin

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 or 175 mg/m2 based on provider preference. Given by IV after completion of doxorubicin/cyclophosphamide therapy

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Patrick Dillon, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038489 on ClinicalTrials.gov