Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
NCT ID: NCT00005581
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1000 participants
INTERVENTIONAL
2000-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating women who have stage II or stage III breast cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms within 35 days of surgery. Arm I: Patients receive epirubicin IV followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 4 courses. Arm II: Patients receive cyclophosphamide IV, epirubicin IV, and fluorouracil IV on day 1. Treatment repeats every 21 days for 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are postmenopausal, or premenopausal and hormone receptor positive, receive tamoxifen orally once a day for 5 years starting on day 1. Patients receive radiotherapy to residual breast after 4 courses of chemotherapy. Quality of life is assessed. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study over 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cyclophosphamide
epirubicin hydrochloride
fluorouracil
paclitaxel
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Not specified Performance status: ECOG 0 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Transaminases, alkaline phosphatase, and gamma glutamyltransferase no greater than 1.5 times upper limit of normal Renal: Not specified Cardiovascular: No heart disease that precludes use of anthracyclines (i.e., myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmias, or valve disease) Other: No concurrent pathology that precludes use of antineoplastic drugs No mental retardation or psychiatric disease that precludes study No other current or prior malignancy within the past 10 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior antineoplastic hormonal therapy Radiotherapy: No postoperative radiotherapy except to residual breast Surgery: See Disease Characteristics
70 Years
FEMALE
No
Sponsors
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IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
OTHER
Principal Investigators
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Riccardo Rosso, MD
Role: STUDY_CHAIR
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Locations
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Ospedale San Lazzaro
Alba, , Italy
Ospedale Civile di Asti
Asti, , Italy
Ospedale Oncologico A. Businco
Cagliari, , Italy
Santo Spirito Hospital
Casale Monferato, , Italy
Ospedale Santa Croce
Cuneo, , Italy
Ospedale Galliera Oncologia
Genoa, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa, , Italy
Ospendale S. Andrea EST
La Spezia, , Italy
Ospedale Civile di Livorno
Livorno, , Italy
Carlo Poma Hospital
Mantova, , Italy
Azienda USSL NO 8
Merate, , Italy
Instituto Scientifico H.S. Raffaele
Milan, , Italy
Ospedale Santa Croce
Moncalieri, , Italy
I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
Ospedale St. Santa Chiara
Pisa, , Italy
USL NO 1
Sanremo, , Italy
Azienda U.S.L. 1 - Sassari
Sassari, , Italy
Ospedale S. Paolo
Savona, , Italy
Osp. Civile USL 18
Sestri Lev., , Italy
Ospedale Sant Anna
Torino, , Italy
Ospedale Evangelico Valdese
Torino, , Italy
OIRM - Sant Anna
Torino, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
Ospedale Maggiore dell' Universita
Trieste, , Italy
Ospedale Molinette
Turin, , Italy
Countries
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Other Identifiers
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INRC-GONO-MIG-5
Identifier Type: -
Identifier Source: secondary_id
NCI-V99-1562
Identifier Type: -
Identifier Source: secondary_id
CDR0000067266
Identifier Type: -
Identifier Source: org_study_id