CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
Celecoxib +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04081389
NCT04081389Phase 1Completed

Phase I Clinical Trial Assessing the Combination of Chemokine Modulation With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Roswell Park Cancer Institute·interventional·Posted Sep 9, 2019·Updated Sep 11, 2023

In Brief

A Phase 1 clinical trial evaluating Celecoxib, Cyclophosphamide, and 5 other interventions for Anatomic Stage 0 Breast Cancer AJCC v8 and 18 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This phase I trial studies how well chemokine modulation therapy and standard chemotherapy given before surgery work in treating patients with early stage triple negative breast cancer. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b, and rintatolimod, may stimulate the immune system and stop tumor cells from growing. Drugs used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy together with standard chemotherapy may work better than giving either therapy alone in treating patients with triple negative breast cancer.

Study Details

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 9, 2019
Enrollment StartDec 6, 2019
Primary CompletionMay 24, 2022
Study CompletionFeb 27, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.8 years ago

Interventions

Celecoxibdrug

Given PO

Cyclophosphamidedrug

Given IV

Doxorubicindrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Paclitaxeldrug

Given IV

Recombinant Interferon Alfa-2bbiological

Given IV

Rintatolimoddrug

Given IV