Status:
ACTIVE_NOT_RECRUITING
Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer
Lead Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborating Sponsors:
Gruppo Italiano Mammella (GIM)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by s...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride, cyclophosphamide, and paclitaxel with vs without fluorouracil and/or pegfilgrastim in women with n...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00433420
Start Date
April 1 2003
End Date
December 1 2025
Last Update
May 8 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.