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Trial record 45 of 102 for:    FEC

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630032
Recruitment Status : Active, not recruiting
First Posted : March 6, 2008
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):

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 chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: Docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: ixabepilone Phase 3

Detailed Description:



  • 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 disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.


  • To compare the 5-year distant metastasis-free survival.
  • To compare the 5-year event-free survival.
  • To compare the 5-year overall survival.
  • To compare the safety profiles for the two chemotherapy regimens.
  • To identify and/or validate predictive-gene expression profiles of clinical response/resistance to the two treatment regimens.
  • To bank frozen and fixed tumor and frozen serum prospectively for future translational studies in both genomics and proteomics (transcriptome and proteome analyses, tissue array analyses).
  • To compare the cost-effectiveness of these 2 regimens.
  • To compare the quality-of-life of patients treated with these 2 regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status (triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor [ER] positive). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks in courses 4-6.
  • Arm II: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone every 3 weeks in courses 4-6.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also complete a quality of life questionnaire periodically.

After completion of study treatment, patients are followed periodically for up to 10 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 762 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.
Actual Study Start Date : September 2007
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ixabepilone

Arm Intervention/treatment
Active Comparator: Arm A
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Drug: cyclophosphamide
500 mg/m² every 3 weeks

Drug: Docetaxel
100 mg/m² every 3 weeks

Drug: epirubicin hydrochloride
100 mg/m² every 3 weeks

Drug: fluorouracil
500 mg/m² every 3 weeks

Experimental: Arm B
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Drug: cyclophosphamide
500 mg/m² every 3 weeks

Drug: epirubicin hydrochloride
100 mg/m² every 3 weeks

Drug: fluorouracil
500 mg/m² every 3 weeks

Drug: ixabepilone
40 mg/m² every 3 weeks

Primary Outcome Measures :
  1. Disease-free survival (DFS) defined as a local, regional, or metastatic relapse, a contralateral breast cancer, or a death of any cause [ Time Frame: at 5 years ]

Secondary Outcome Measures :
  1. DFS for triple-negative and ER+/PR-/HER2- subgroups [ Time Frame: at 5 years ]
  2. Distant metastasis-free survival for whole population and subgroups [ Time Frame: at 5 years ]
  3. Event-free survival defined as local, regional, or metastatic relapse, a contralateral breast cancer, a second cancer, or death of any cause [ Time Frame: at 5 years ]
  4. Overall survival [ Time Frame: at 5 years ]
  5. Toxicity as measured by CTC-AE scale version [ Time Frame: During treatment phase ]
  6. Biotheque transcriptome and proteome analysis [ Time Frame: after survival analysis ]
  7. Quality of life as measured by QlQ C30/Br23 [ Time Frame: During treatment phase ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630032

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Sponsors and Collaborators
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Principal Investigator: Mario Campone, MD ICO Centre Regional Rene Gauducheau

Additional Information:
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Responsible Party: UNICANCER Identifier: NCT00630032     History of Changes
Other Study ID Numbers: PACS08 - UC-0140/0610
PACS-08/0610 ( Other Identifier: UNICANCER )
2006-006494-24 ( EudraCT Number )
PACS08-Tavlx ( Other Identifier: UNICANCER )
BMS-UNICANCER-PACS-08/0610 ( Other Identifier: UNICANCER )
AMGEN-UNICANCER-PACS-08/0610 ( Other Identifier: UNICANCER )
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by UNICANCER:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors