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Status:

COMPLETED

Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer

Lead Sponsor:

UNICANCER

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination ch...

Detailed Description

OBJECTIVES: Primary * To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year dis...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Inclusion criteria:
  • Histologically proven invasive unilateral breast cancer (regardless of the type)
  • Initial clinical condition compatible with complete initial resection
  • No residual macro or microscopic tumor after surgical excision
  • Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :
  • Stage II or III disease
  • pT \>20 mm (T1-4)
  • Patients must meet 1 of the following hormone-receptor criteria:
  • Node-positive patients: triple-negative\* tumor (HER2 negative, estrogen-receptor \[ER\] negative, and progesterone receptor \[PR\] negative) OR double-negative (HER2 negative, PR negative, and ER+)
  • Node-negative patients: triple-negative\* tumor only
  • NOTE: \*Hormone-receptor negativity is defined as ER \<10% and PR \<10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative
  • Must be able to begin chemotherapy no later than day 49 after the initial surgery
  • Exclusion criteria:
  • Clinically or radiologically detectable metastases (M0)
  • Bilateral breast cancer or contralateral ductal carcinoma in situ
  • Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type
  • Any tumor ≥T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)
  • HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive
  • Any clinically or radiologically suspect and non-explored damage to the contralateral breast
  • PATIENT CHARACTERISTICS:
  • Inclusion criteria:
  • Female
  • Pre- or postmenopausal
  • ECOG performance status 0-1
  • Peripheral neuropathy ≤grade 1
  • Neutrophil count ≥2,000/mm³
  • Platelet count ≥100,000/mm³
  • Hemoglobin \>9 g/dL
  • AST and ALT ≤1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤2.5 times ULN
  • Total bilirubin ≤1.0 times ULN
  • Serum creatinine ≤1.5 times ULN
  • LVEF ≥50% by MUGA scan or echocardiography
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
  • Exclusion criteria:
  • Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer
  • Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study
  • Clinically significant cardiovascular disease within the past 6 months including any of the following:
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled hypertension (i.e., blood pressure \>150/90 mm Hg)
  • Myocardial infarction
  • Cerebral vascular accidents
  • Known prior severe hypersensitivity reactions to agents containing Cremophor EL
  • Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Patients deprived of liberty or placed under the authority of a tutor
  • PRIOR CONCURRENT THERAPY:
  • At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered
  • At least 3 weeks since prior major surgery and adequately recovered
  • No prior chemotherapy, hormonal therapy, or radiotherapy
  • More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:
  • Amiodarone
  • Clarithromycin
  • Amprenavir
  • Delavirdine
  • Voriconazole
  • Erythromycin
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Indinavir
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • No concurrent participation in another therapeutic trial involving an experimental drug

Exclusion

    Key Trial Info

    Start Date :

    September 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 3 2020

    Estimated Enrollment :

    762 Patients enrolled

    Trial Details

    Trial ID

    NCT00630032

    Start Date

    September 1 2007

    End Date

    September 3 2020

    Last Update

    February 21 2024

    Active Locations (86)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 22 (86 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    CCOP - Colorado Cancer Research Program

    Denver, Colorado, United States, 80224

    3

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    4

    CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, United States, 46601