Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer

NCT ID: NCT00053911

Last Updated: 2014-12-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

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, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.

Detailed Description

OBJECTIVES:

• Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
• Compare the overall survival of women treated with these regimens.
• Determine the tolerance of these women to the chemotherapy regimen.
• Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease.

• Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients are examined on days 1 and 63.

Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:

• Oral tamoxifen daily for 5 years
• Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years
• Oral LHRH agonist therapy (e.g., goserelin) for 3 years
• Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo radiotherapy and may also undergo second complete resection.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

anastrozole

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

goserelin acetate

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• No contralateral breast cancer
• Local tumor recurrence more than 6 months after conservative surgery
• Complete or conservative resection of the recurrent tumor NOTE: Initial complete surgical resection not allowed
• No local inflammatory disease or disease that is not amenable to complete surgical resection
• No positive axillary lymph nodes
• No distant metastases, including subclavicular lymph nodes
• Hormone receptor status:

• Hormone receptor status known

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Sex

• Female

Menopausal status

• Menopausal status known

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)
• Transaminases no greater than 1.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• No chronic hepatitis B
• No active hepatitis C

Renal

• Not specified

Cardiovascular

• Cardiac function normal by echocardiogram or isotopes

Other

• No contraindications to anthracyclines such as any of the following:

• Prior doxorubicin over 300 mg/m^2
• Prior epirubicin over 600 mg/m^2
• Prior mitoxantrone over 90 mg/m^2
• No other invasive malignancy
• No chronic somatic or psychiatric condition that would preclude study participation
• No familial, social, geographic, or psychological reason that would preclude study participation
• Not pregnant
• Fertile patients must use effective contraception
• HIV negative
• CA 153 no greater than 2 times ULN

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Patient Characteristics-Other
• No prior neoadjuvant chemotherapy

Endocrine therapy

• No prior neoadjuvant hormonal therapy

Radiotherapy

• No prior neoadjuvant radiotherapy

Surgery

• See Disease Characteristics
• At least 41 days since prior surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Principal Investigators

Gilles Romieu, MD

Role: STUDY_CHAIR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Clinique Claude Bernard

Albi, , France

Centre Paul Papin

Angers, , France

Centre Hospitalier d'Annecy

Annecy, , France

Institut Sainte Catherine

Avignon, , France

Institut Bergonie

Bordeaux, , France

C.H. Bourg En Bresse

Bourg-en-Bresse, , France

CHU Hopital A. Morvan

Brest, , France

Centre Hospitalier General

Brivé, , France

Centre Regional Francois Baclesse

Caen, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Hospitalier Compiegne

Compiègne, , France

Clinique du Petit Colmouilins

Harfleur, , France

Centre Oscar Lambret

Lille, , France

Institut J. Paoli and I. Calmettes

Marseille, , France

Hopital Notre-Dame de Bon Secours

Metz, , France

C.H. General Andre Boulloche

Montbéliard, , France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Centre Hospitalier de Mulhouse

Mulhouse, , France

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, , France

Clinique Saint - Pierre

Perpignan, , France

Centre Eugene Marquis

Rennes, , France

Clinique Armoricaine De Radiologie

Saint Brieux, , France

Polyclinique de L'Ormeau

Tarbes, , France

Institut Claudius Regaud

Toulouse, , France

Hopital J. Ducuing

Toulouse, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

FRE-FNCLCC-PACS-03/003

Identifier Type: -

Identifier Source: secondary_id

EU-20237

Identifier Type: -

Identifier Source: secondary_id

PACS03

Identifier Type: -

Identifier Source: org_study_id