Spots Global Cancer Trial Database for Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)
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Trial Identification
Brief Title: Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)
Official Title: 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
Study ID: NCT00790894
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hippokration General Hospital, Oncology Department, Athens, , Greece
University Hospital Attikon, Second Department of Internal Medicine, Oncology Section, Athens, , Greece
Agii Anargiri Cancer Hospital, Third Department of Medical Oncology, Athens, , Greece
Hygeia Hospital, First Deparment of Medical Oncology, Athens, , Greece
Hygeia Hospital, Second Department of Medical Oncology, Athens, , Greece
Alexandra Hospital, Department of Clinical Therapeutics, Athens, , Greece
University General Hospital of Ioannina, Medical Oncology Department, Ioannina, , Greece
University Hospital of Larisa, Department of Medical Oncology, Larisa, , Greece
University Hospital of Patras, Department of Medicine, Division of Oncology, Patras, , Greece
Metropolitan Hospital, First Department of Medical Oncology, Piraeus, , Greece
Metropolitan Hospital, Second Dept of Medical Oncology, Piraeus, , Greece
"Theageneio" Cancer Hospital, Third Department of Medical Oncology, Thessaloniki, , Greece
"Papageorgiou" General Hospital, Department of Medical Oncology, Thessaloniki, , Greece
Contact Details
Name: George Fountzilas
Affiliation: Papageorgiou General Hospital
Role: PRINCIPAL_INVESTIGATOR
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