Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi
AstraZeneca
Information provided by:
Finnish Breast Cancer Group
ClinicalTrials.gov Identifier:
NCT00114816
First received: June 17, 2005
Last updated: May 18, 2007
Last verified: May 2007

June 17, 2005
May 18, 2007
January 2004
Not Provided
Recurrence-free survival
Same as current
Complete list of historical versions of study NCT00114816 on ClinicalTrials.gov Archive Site
  • Adverse event rate (CTCAE v. 3.0)
  • Overall survival
Same as current
Not Provided
Not Provided
 
Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer
A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide, Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide, Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer

This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The study participants are randomly allocated to receive either 3 cycles of docetaxel followed by 3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and capecitabine). The study participants are required to to have a medium to high risk for breast cancer recurrence. The primary aim of the study is to investigate whether addition of capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free survival.

This is an open-label, two-arm, randomized multi-center phase III trial to compare efficacy and safety of a taxane-anthracycline regimen to a taxane-anthracycline-capecitabine regimen as adjuvant treatment of early breast cancer with an intermediate-to-high risk of cancer recurrence.

Patients diagnosed with early breast cancer with an estimated risk of 25% or greater for distant recurrence within 5 years from the diagnosis will be randomly allocated to one of the following 2 arms (1:1):

  • Arm A -- 3 cycles of docetaxel 80 mg/m² intravenous (i.v.) (repeated on day [d.] 22); followed by 3 cycles of CEF (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v., 5-fluorouracil 600 mg/m2 i.v., repeated on d. 22)
  • Arm B -- 3 cycles of TX (docetaxel 60 mg/m² i.v., capecitabine twice daily 900 mg/m² given orally on days 1-15 of the cycle; cycle repeated on d. 22); followed by 3 cycles of CEX (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v, capecitabine twice daily 900 mg/m² on days 1-15 of the cycle; cycle repeated on d. 22)

Locoregional radiotherapy is given according to the institutional practice after completing adjuvant chemotherapy (Tx3/CEFx3 or TXx3/CEXx3).

All patients with ER and/or PgR positive disease will receive adjuvant endocrine therapy. This will consist of 1 mg p.o. anastrozole (ArimidexR) given for 60 months in women who were post-menopausal prior to chemotherapy (no menstrual periods for > 6 months) or of tamoxifen 20 mg p.o. for 60 months in women who were pre-menopausal prior to chemotherapy.

Use of trastuzumab is allowed in HER-2 positive disease.

Patients will be followed up for 5 years post-randomization.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: capecitabine
  • Drug: docetaxel
Not Provided
Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtiö K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. Epub 2009 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
April 2007
Not Provided

Inclusion Criteria:

To be eligible for inclusion in the study, each patient must fulfill each of the criteria below.

  • Have provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Be female and 18 years of age or older.
  • Have histologically confirmed invasive breast cancer.
  • High risk of breast cancer recurrence (> 25% within the first 5 years without adjuvant therapy, > 35% within the first 10 years) with one of the following:

    • Regional node positive disease (pN+; tumor cells or tumor cell clusters < 0.2 mm in diameter are not counted as metastases);
    • Pathological N0 and PgR- and tumor size > 20 mm.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

  • > 65 years of age.
  • ”Special type” histology (mucinous, papillary, medullary, or tubular breast cancer), when pN0.
  • ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
  • Presence of distant metastases.
  • Previous chemotherapy in the neoadjuvant setting.
  • Non-ambulatory or WHO performance status > 1.
  • Pregnant or lactating women. Women of childbearing potential (menstruating within 6 months of study entry or with no hysterectomy and age < 55) with either a positive or no pregnancy test at baseline.
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method. (Post-menopausal women must have been amenorrheic for at least 6 months to be considered of non-childbearing potential).
  • More than 12 weeks between breast surgery and date of randomization.
  • Organ allografts with immunosuppressive therapy required.
  • Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
  • Participation in any investigational drug study within 4 weeks preceding treatment start.
  • Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix.
  • Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
  • Abnormal laboratory values:

    • Hemoglobin < 10.0 g/dL, neutrophils < 1.5 x 10^9/L, platelet count < 120 x 10^9/L;
    • Serum creatinine > 1.5 x Upper Limit of Normal (ULN);
    • Creatinine clearance (calculated per Cockroft and Gault) < 50 mL/min;
    • Serum bilirubin > ULN;
    • ALAT > 1.5 x ULN;
    • Alkaline phosphatase > 2.5 x ULN.
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  • Lack of physical integrity of the upper gastrointestinal tract or those who have clinically significant malabsorption syndrome.
  • Inability to swallow tablets.
  • Life expectancy of less than 3 months.
  • Unwilling or unable to comply with the protocol for the duration of the study.
  • Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00114816
FBCG Protocol No. 01-2003, Roche protocol number MO17728
Not Provided
Not Provided
Finnish Breast Cancer Group
  • Hoffmann-La Roche
  • Sanofi
  • AstraZeneca
Principal Investigator: Heikki T Joensuu, M.D., prof. Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland
Finnish Breast Cancer Group
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP