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Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer

NCT00894504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2015-05-15

Study results available
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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.

Conditions

Interventions

DRUG

Panitumumab

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

DRUG

Carboplatin

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

DRUG

Gemcitabine

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

Sponsors & Collaborators

Principal Investigators

  • Denise A Yardley, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00894504 on ClinicalTrials.gov