Status:
COMPLETED
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
Lead Sponsor:
Finnish Breast Cancer Group
Collaborating Sponsors:
Hoffmann-La Roche
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00114816
Start Date
January 1 2004
End Date
April 1 2007
Last Update
May 21 2007
Active Locations (1)
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1
Department of Oncology, Helsinki University Central Hospital, Finland
Helsinki, Finland, FIN-00029