A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients
18 Years
70 Years
Female
Breast Cancer
Trial Information
A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride,
cyclophosphamide, and paclitaxel with vs without fluorouracil and/or pegfilgrastim in
women with node-positive breast cancer.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4
treatment arms.
- Arm I: Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1.
Treatment repeats every 3 weeks for 4 courses. Patients then receive paclitaxel IV over
3 hours on day 1. Treatment with paclitaxel repeats every 3 weeks for 4 courses.
- Arm II: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and
cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients
then receive paclitaxel as in arm I.
- Arm III: Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1
and pegfilgrastim subcutaneously (SC) on day 4. Treatment repeats every 2 weeks for 4
courses. Patients then receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim
subcutaneously (SC) on day 4. Treatment with paclitaxel and pegfilgrastim repeats every
2 weeks for 4 courses.
- Arm IV: Patients receive fluorouracil IV, epirubicin hydrochloride IV, and
cyclophosphamide IV on day 1 and pegfilgrastim SC on day 4. Treatment repeats every 2
weeks for 4 courses. Patients then receive paclitaxel and pegfilgrastim as in arm III.
In all arms, treatment continues in the absence of disease progression or unacceptable
toxicity. After completion of chemotherapy with or without pegfilgrastim, patients may
undergo external-beam radiation therapy at the discretion of treating center. Patients with
positive estrogen and/or progesterone receptor tumor receive tamoxifen for 5 years.
After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary breast cancer
- No histology other than carcinoma
- Node-positive disease
- Must have at least 1 involved axillary node or internal mammary node
- Previously resected disease
- Has undergone radical surgery (i.e., mastectomy or conservative surgery) with
axillary node dissection within the past 7 weeks
- No inflammatory carcinoma
- No prior or concurrent ipsilateral or contralateral invasive breast carcinoma
- No metastatic disease, including metastasis in the ipsilateral supraclavicular lymph
nodes
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm³
- WBC ≥ 4,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No chronic liver or renal disease
- No other serious medical illness requiring medication
- No other malignancy except adequately treated, cone-biopsied in situ carcinoma of the
cervix or basal cell or squamous cell carcinoma of the skin
- No symptomatic peripheral neuropathy > grade 2
- No hypersensitivity to study drugs or their components
- No recent myocardial infarction, congestive heart failure, or serious arrhythmia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
- No prior cytotoxic regimens
- No prior radiation therapy, except for intraoperative radiation therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
Principal Investigator
Marco Venturini, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Institute for Cancer Research, Italy
Authority:
United States: Federal Government
Study ID:
CDR0000528056
NCT ID:
NCT00433420
Start Date:
April 2003
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
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