NCT00790894

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

Phase II Randomized Trial of Ixabepilone Administered Weekly or Every Three Weeks in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Chemotherapy in the Neo-adjuvant or Adjuvant Setting

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hellenic Cooperative Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients with measurable metastatic breast cancer that have been treated in the adjuvant or neo-adjuvant setting with chemotherapy will be considered for this study. Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease. Patients who fulfil the eligibility criteria, and have signed inform consent for the trial will be centrally randomized by electronic means to one of two ixabepilone treatment arms. Stratification factors will include: time to recurrence from adjuvant treatment, calculated from the date of the last dose of adjuvant treatment to the date of relapse (≤ 1 year vs. \> 1 year); and previous chemotherapy with taxane regimen in the neo-adjuvant or adjuvant setting (yes vs. no). Randomization will be balanced by site.Treatment Protocol· Arm A \[standard once every three weeks schedule\]:Ixabepilone \[BMS-247550\] will be administered on Day 1 (D1) every three weeks as a 3-hour infusion at a dose of 40 mg/m2. · Arm B \[weekly schedule\]:Ixabepilone \[BMS-247550\] will be administered weekly for three weeks as a 3-hour infusion at a dose of 20 mg/m2, followed by one week-off.Treatment can be continued until consent withdrawal by the patient, intolerable toxicity or documented disease progression.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2008-11-14
• Last updated: 2011-05-18

Locations

13 sites across 1 country: Greece