CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 62 enrolled
Drug / intervention
pegylated liposomal doxorubicin hydrochloride +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/NCT02315196
NCT02315196Phase 2Active

A Phase 2 Trial of Liposomal Doxorubicin and Carboplatin in Patients With ER, PR, HER2 Negative Breast Cancer (TNBC)

Rutgers, The State University of New Jersey·interventional·Posted Dec 11, 2014·Updated Mar 29, 2023

In Brief

A Phase 2 clinical trial evaluating pegylated liposomal doxorubicin hydrochloride, epirubicin hydrochloride, and 5 other interventions for Estrogen Receptor-negative Breast Cancer and 8 related conditions. Active but no longer recruiting, targeting 62 participants across 1 site.

Detailed Summary

This phase II trial studies how well pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel work in treating patients with stage II-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative). Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, carboplatin, and paclitaxel, 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 pegylated liposomal doxorubicin hydrochloride and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving pegylated liposomal doxorubicin hydrochloride and carboplatin followed by surgery and paclitaxel may be an effective treatment for breast cancer.

Study Details

Timeline

Phase 2Active
2015201620172018201920202021202220232024202520262027202820292030203120322033203420352036203720382039204020412042
First PostedDec 11, 2014
Enrollment StartFeb 25, 2015
Primary CompletionFeb 8, 2021
Study CompletionJul 1, 2041
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 11.6 years ago

Interventions

pegylated liposomal doxorubicin hydrochloridedrug

Given IV

epirubicin hydrochloridedrug

Given IV

carboplatindrug

Given IV

therapeutic conventional surgeryprocedure

Undergo definitive surgery

paclitaxeldrug

Given IV

laboratory biomarker analysisother

Correlative studies

quality-of-life assessmentother

Ancillary studies