CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
Panitumumab +2 moredrug
Likely dose
Panitumumab 6 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/NCT00894504
NCT00894504Phase 2Completed
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A Phase II Trial of Panitumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted May 7, 2009·Updated May 15, 2015

In Brief

A Phase 2 clinical trial evaluating Panitumumab, Carboplatin, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 71 participants across 17 sites.

Detailed Summary

In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsAmgen, Eli Lilly and Company

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2009
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.2 years ago

Interventions

Panitumumabdrug

6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Carboplatindrug

AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Gemcitabinedrug

1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)