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

Phase 3

• Conditions: Breast Cancer

• Registration Number: NCT00005581
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Study Timeline

• Study First Submitted: 2000-05-02
• Study Start: 2000-06
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Status Verified: 2007-06
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

Ospedale S. Paolo; 🇮🇹 Savona, Italy

Ospedale Oncologico A. Businco; 🇮🇹 Cagliari, Italy

I.R.C.C.S. Policlinico San Matteo; 🇮🇹 Pavia, Italy

Instituto Scientifico H.S. Raffaele; 🇮🇹 Milan, Italy

USL NO 1; 🇮🇹 San Remo, Italy

Ospedale Civile di Asti; 🇮🇹 Asti, Italy

Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa, Italy

Santo Spirito Hospital; 🇮🇹 Casale Monferato, Italy

Ospedale Santa Croce; 🇮🇹 Moncalieri, Italy

Ospedale San Lazzaro; 🇮🇹 Alba, Italy

Ospedale Galliera Oncologia; 🇮🇹 Genoa, Italy

Ospedale St. Santa Chiara; 🇮🇹 Pisa, Italy

Ospedale Civile di Livorno; 🇮🇹 Livorno, Italy

Carlo Poma Hospital; 🇮🇹 Mantova, Italy

Ospendale S. Andrea EST; 🇮🇹 La Spezia, Italy

Azienda USSL NO 8; 🇮🇹 Merate, Italy

Azienda U.S.L. 1 - Sassari; 🇮🇹 Sassari, 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