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Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer

NCT00866905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-11-22

Study results available
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Summary

We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical

studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Conditions

Interventions

DRUG

Ixabepilone

40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles

DRUG

Cyclophosphamide

600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles

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
2009-04-30
Primary Completion
2014-07-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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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 NCT00866905 on ClinicalTrials.gov