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Neo-Adjuvant Study in Triple Negative Breast Cancer Patients

NCT01097642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-22

Study results available
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Summary

Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients with metastatic breast cancer after failing other treatments. Cetuximab is active against tumors expressing epidermal growth factor receptor w/demonstrated activity in head \& neck and colorectal tumors and may be effective in some breast cancers known to express EGFR. Study seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).

Conditions

Interventions

DRUG

Cetuximab

Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.

DRUG

Ixabepilone

Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles.

Sponsors & Collaborators

Principal Investigators

  • Jenny Chang, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-10
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01097642 on ClinicalTrials.gov