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

December 14, 2014 updated by: UNICANCER

Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery

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.

Study Overview

Status

Terminated

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Albi, France, 81000
    - Clinique Claude Bernard
  - Angers, France, 49036
    - Centre Paul Papin
  - Annecy, France, 74011 Cedex
    - Centre hospitalier d'Annecy
  - Avignon, France, 84082
    - Institut Sainte Catherine
  - Bordeaux, France, 33076
    - Institut Bergonie
  - Bourg En Bresse, France, 01012
    - C.H. Bourg En Bresse
  - Brest, France, 29609
    - CHU Hopital A. Morvan
  - Brive, France, 19101
    - Centre Hospitalier Général
  - Caen, France, 14076
    - Centre Regional Francois Baclesse
  - Clermont-Ferrand, France, 63011
    - Centre Jean Perrin
  - Compiegne, France, 60321
    - Centre Hospitalier COMPIEGNE
  - Harfleur, France, 76700
    - Clinique du Petit Colmouilins
  - Lille, France, 59020
    - Centre Oscar Lambret
  - Marseille, France, 13273
    - Institut J. Paoli and I. Calmettes
  - Metz, France, 57038
    - Hopital Notre-Dame de Bon Secours
  - Montbeliard, France, 25209
    - C.H. General Andre Boulloche
  - Montpellier, France, 34298
    - Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  - Mulhouse, France, 68051
    - Centre Hospitalier de Mulhouse
  - Nantes-Saint Herblain, France, 44805
    - Centre Regional Rene Gauducheau
  - Perpignan, France
    - Clinique Saint - Pierre
  - Rennes, France, 35042
    - Centre Eugene Marquis
  - Saint Brieux, France, F-22015
    - Clinique Armoricaine de Radiologie
  - Tarbes, France, 65000
    - Polyclinique de l'Ormeau
  - Toulouse, France, 31052
    - Institut Claudius Regaud
  - Toulouse, France
    - Hopital J. Ducuing
  - Villejuif, France, F-94805
    - Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the disease free survival Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the overall survival Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

Study Chair: Gilles Romieu, MD, Institut du Cancer de Montpellier - Val d'Aurelle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria