CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Panitumumab +5 moredrug
Likely dose
Panitumumab 2.5 mg/kgfrom 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/NCT01036087
NCT01036087Phase 2Completed

Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression

M.D. Anderson Cancer Center·interventional·Posted Dec 21, 2009·Updated Mar 30, 2023

In Brief

A Phase 2 clinical trial evaluating Panitumumab, Nab-paclitaxel, and 4 other interventions for Breast Cancer. Completed, enrolled 47 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2009
Enrollment StartNov 1, 2010
Primary CompletionFeb 11, 2016
Study CompletionAug 9, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.5 years ago

Interventions

Panitumumabdrug

2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.

Nab-paclitaxeldrug

100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.

Carboplatindrug

AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.

5-Fluorouracildrug

500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Epirubicindrug

100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).

Cyclophosphamidedrug

500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).