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

NCT00005581 | Unknown Phase 3

• 3 other identifiers: CDR0000067266INRC-GONO-MIG-5NCI-V99-1562
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 25

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Interventions

cyclophosphamide DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: lead

Study Sites (25)

Ospedale San Lazzaro

Alba, 12051, Italy

Location

Ospedale Civile di Asti

Asti, 14100, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09124, Italy

Location

Santo Spirito Hospital

Casale Monferato, 1-15033, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Ospedale Galliera Oncologia

Genoa, 16128, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Ospendale S. Andrea EST

La Spezia, 19100, Italy

Location

Ospedale Civile di Livorno

Livorno, 57121, Italy

Location

Carlo Poma Hospital

Mantova, 46100, Italy

Location

Azienda USSL NO 8

Merate, 22055, Italy

Location

Instituto Scientifico H.S. Raffaele

Milan, 20132, Italy

Location

Ospedale Santa Croce

Moncalieri, 10024, Italy

Location

I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale St. Santa Chiara

Pisa, 56100, Italy

Location

USL NO 1

Sanremo, 18038, Italy

Location

Azienda U.S.L. 1 - Sassari

Sassari, 07100, Italy

Location

Ospedale S. Paolo

Savona, 17100, Italy

Location

Osp. Civile USL 18

Sestri Lev., 16039, Italy

Location

Ospedale Sant Anna

Torino, 10100, Italy

Location

Ospedale Evangelico Valdese

Torino, 10125, Italy

Location

OIRM - Sant Anna

Torino, 10126, Italy

Location

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

Ospedale Maggiore dell' Universita

Trieste, 34100, Italy

Location

Ospedale Molinette

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Fluorouracil; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Riccardo Rosso, MD

  IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: May 20, 2004
• Study Start: June 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2007-06

Locations

IT (25)