Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Biological: Trastuzumab; Drug: Cyclophosphamide; Drug: docetaxel; Drug: Epirubicin; Drug: Fluorouracil

• Registration Number: NCT00054587
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

Detailed Description

OBJECTIVES:

* Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.

* Determine survival of patients treated with these regimens.

* Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.

* Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.

* Evaluate the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.

* Part I: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.

* Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I.

Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.

Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.

* Part II: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.

* Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3010

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 FEC	Trastuzumab	Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
6 FEC	Cyclophosphamide	Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
6 FEC	Epirubicin	Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
6 FEC	Fluorouracil	Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
6 DE	Trastuzumab	Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I
6 DE	docetaxel	Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I
6 DE	Epirubicin	Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	5 years from randomization

Secondary Outcome Measures

Name	Time	Method
Herceptin safety	5 years from randomization
Overall survival	5 years from randomization

Trial Locations

Locations (29)

Centre Paul Papin; 🇫🇷 Angers, France

Centre Hospitalier d'Annecy; 🇫🇷 Annecy, France

Institut Bergonie; 🇫🇷 Bordeaux, France

C.H. Bourg En Bresse; 🇫🇷 Bourg En Bresse, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Hopital Intercommunal De Creteil; 🇫🇷 Creteil, France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc; 🇫🇷 Dijon, France

Institut Prive de Cancerologie; 🇫🇷 Grenoble, France

Clinique du Petit Colmouilins; 🇫🇷 Harfleur, France

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