Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
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Trial Identification
Brief Title: Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Official Title: Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study
Study ID: NCT00005581
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective for breast cancer. 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: OBJECTIVES: I. Compare overall survival and disease free survival after adjuvant chemotherapy with epirubicin plus paclitaxel versus cyclophosphamide, epirubicin, and fluorouracil in women with stage IIA, IIB, or III breast cancer. II. Compare quality of life in these women with these treatment regimens. 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, San Remo, , 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
Contact Details
Name: Riccardo Rosso, MD
Affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Role: STUDY_CHAIR
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