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Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)

NCT00790894 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-05-18

No results posted yet for this study

Summary

This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to receive Ixabepilone either every three weeks, or weekly for three weeks followed by one week off. Patients will be treated until consent withdrawal, intolerable toxicity or documented disease progression

Conditions

Interventions

DRUG

ixabepilone

Arm A: ixabepilone will be given at a dose of 40 mg/m2 as a 3-hour intravenous infusion on Day 1 in a 21 days cycle.

DRUG

ixabepilone

Arm B: ixabepilone will be given at a dose of 20 mg/m2 as a 3-hour intravenous infusion on Days 1, 8 and 15, then 1 week off in a 28-days cycle.

Sponsors & Collaborators

  • Hellenic Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • George Fountzilas · Papageorgiou General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

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 NCT00790894 on ClinicalTrials.gov