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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053911
First received: February 5, 2003
Last updated: November 6, 2010
Last verified: January 2005
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: cyclophosphamide
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: goserelin acetate
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053911

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

No publications provided

ClinicalTrials.gov Identifier: NCT00053911     History of Changes
Other Study ID Numbers: CDR0000269549, FRE-FNCLCC-PACS-03/003, EU-20237
Study First Received: February 5, 2003
Last Updated: November 6, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Fluorouracil
Goserelin
Tamoxifen
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 25, 2014