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| Sponsored by: |
Istituto Nazionale per la Ricerca sul Cancro |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005581 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 |
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2000 |
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| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed stage IIA, IIB, or III breast cancer treated with radical surgery (e.g., mastectomy, quadrantectomy, tumorectomy) and axillary lymph node dissection Positive axillary lymph nodes No more than 9 metastatic lymph nodes No distant metastases or local or locoregional disease No more than 5 weeks between surgery and beginning of study Hormone receptor status: Not specified
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
Contacts and Locations| Italy | |
| Azienda U.S.L. 1 - Sassari | |
| Sassari, Italy, 07100 | |
| Azienda USSL NO 8 | |
| Merate, Italy, 22055 | |
| Carlo Poma Hospital | |
| Mantova, Italy, 46100 | |
| I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Instituto Scientifico H.S. Raffaele | |
| Milan, Italy, 20132 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| OIRM - Sant Anna | |
| Torino, Italy, 10126 | |
| Osp. Civile USL 18 | |
| Sestri Lev., Italy, 16039 | |
| Ospedale Civile di Asti | |
| Asti, Italy, 14100 | |
| Ospedale Civile di Livorno | |
| Livorno, Italy, 57121 | |
| Ospedale Evangelico Valdese | |
| Torino, Italy, 10125 | |
| Ospedale Galliera Oncologia | |
| Genoa, Italy, 16128 | |
| USL NO 1 | |
| San Remo, Italy, 18038 | |
| Ospedale Mauriziano Umberto I | |
| Torino, Italy, 10128 | |
| Ospedale Molinette | |
| Turin, Italy, 10126 | |
| Ospedale Oncologico A. Businco | |
| Cagliari, Italy, 09124 | |
| Ospedale S. Paolo | |
| Savona, Italy, 17100 | |
| Ospedale San Lazzaro | |
| Alba, Italy, 12051 | |
| Ospedale Sant Anna | |
| Torino, Italy, 10100 | |
| Ospedale Santa Croce | |
| Cuneo, Italy, 12100 | |
| Ospedale Santa Croce | |
| Moncalieri, Italy, 10024 | |
| Ospedale St. Santa Chiara | |
| Pisa, Italy, 56100 | |
| Ospendale S. Andrea EST | |
| La Spezia, Italy, 19100 | |
| Santo Spirito Hospital | |
| Casale Monferato, Italy, 1-15033 | |
| Ospedale Maggiore dell' Universita | |
| Trieste, Italy, 34100 | |
| Study Chair: | Riccardo Rosso, MD | Istituto Nazionale per la Ricerca sul Cancro |
More Information
| Study ID Numbers: | CDR0000067266, INRC-GONO-MIG-5, NCI-V99-1562 |
| Study First Received: | May 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005581 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
|
Antimetabolites Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Cyclophosphamide Epirubicin Immunosuppressive Agents |
Anti-Bacterial Agents Paclitaxel Fluorouracil Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Skin Diseases Mitosis Modulators |
Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Epirubicin Pharmacologic Actions Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
