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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005581
First received: May 2, 2000
Last updated: December 17, 2013
Last verified: June 2007
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1000
Study Start Date: June 2000
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

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005581

Locations
Italy
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
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospedale Galliera Oncologia
Genoa, Italy, 16128
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
USL NO 1
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 Mauriziano Umberto I
Torino, Italy, 10128
Ospedale Evangelico Valdese
Torino, Italy, 10125
OIRM - Sant Anna
Torino, Italy, 10126
Ospedale Maggiore dell' Universita
Trieste, Italy, 34100
Ospedale Molinette
Turin, Italy, 10126
Sponsors and Collaborators
National Institute for Cancer Research, Italy
Investigators
Study Chair: Riccardo Rosso, MD National Institute for Cancer Research, Italy
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005581     History of Changes
Other Study ID Numbers: CDR0000067266, INRC-GONO-MIG-5, NCI-V99-1562
Study First Received: May 2, 2000
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Epirubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014