Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005581
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2004
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: paclitaxel Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Primary Purpose: Treatment
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 Start Date : June 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005581

Ospedale San Lazzaro
Alba, Italy, 12051
Ospedale Civile di Asti
Asti, Italy, 14100
Ospedale Oncologico A. Businco
Cagliari, Italy, 09124
Santo Spirito Hospital
Casale Monferato, Italy, 1-15033
Ospedale Santa Croce
Cuneo, Italy, 12100
Ospedale Galliera Oncologia
Genoa, Italy, 16128
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospendale S. Andrea EST
La Spezia, Italy, 19100
Ospedale Civile di Livorno
Livorno, Italy, 57121
Carlo Poma Hospital
Mantova, Italy, 46100
Azienda USSL NO 8
Merate, Italy, 22055
Instituto Scientifico H.S. Raffaele
Milan, Italy, 20132
Ospedale Santa Croce
Moncalieri, Italy, 10024
I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Ospedale St. Santa Chiara
Pisa, Italy, 56100
San Remo, Italy, 18038
Azienda U.S.L. 1 - Sassari
Sassari, Italy, 07100
Ospedale S. Paolo
Savona, Italy, 17100
Osp. Civile USL 18
Sestri Lev., Italy, 16039
Ospedale Sant Anna
Torino, Italy, 10100
Ospedale Evangelico Valdese
Torino, Italy, 10125
OIRM - Sant Anna
Torino, Italy, 10126
Ospedale Mauriziano Umberto I
Torino, Italy, 10128
Ospedale Maggiore dell' Universita
Trieste, Italy, 34100
Ospedale Molinette
Turin, Italy, 10126
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study Chair: Riccardo Rosso, MD IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Identifier: NCT00005581     History of Changes
Other Study ID Numbers: CDR0000067266
First Posted: May 20, 2004    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors