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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
anastrozole
cyclophosphamide
docetaxel
epirubicin hydrochloride
fluorouracil
goserelin acetate
tamoxifen citrate
adjuvant therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Claude Bernard
  • Centre Paul Papin
  • Centre Hospitalier d'Annecy
  • Institut Sainte Catherine
  • Institut Bergonie
  • C.H. Bourg En Bresse
  • CHU Hopital A. Morvan
  • Centre Hospitalier General
  • Centre Regional Francois Baclesse
  • Centre Jean Perrin
  • Centre Hospitalier Compiegne
  • Clinique du Petit Colmouilins
  • Centre Oscar Lambret
  • Institut J. Paoli and I. Calmettes
  • Hopital Notre-Dame de Bon Secours
  • C.H. General Andre Boulloche
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Hospitalier de Mulhouse
  • Centre Regional Rene Gauducheau
  • Clinique Saint - Pierre
  • Centre Eugene Marquis
  • Clinique Armoricaine De Radiologie
  • Polyclinique de L'Ormeau
  • Institut Claudius Regaud
  • Hopital J. Ducuing
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Evaluation of the disease free survival

Secondary Outcome Measures

Evaluation of the overall survival

Full Information

First Posted
February 5, 2003
Last Updated
December 14, 2014
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00053911
Brief Title
Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Study Start Date
November 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UNICANCER

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anastrozole
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Evaluation of the disease free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Evaluation of the overall survival
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Romieu, MD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Centre Hospitalier d'Annecy
City
Annecy
ZIP/Postal Code
74011 Cedex
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
C.H. Bourg En Bresse
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
CHU Hopital A. Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Hospitalier General
City
Brive
ZIP/Postal Code
19101
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Hospitalier Compiegne
City
Compiegne
ZIP/Postal Code
60321
Country
France
Facility Name
Clinique du Petit Colmouilins
City
Harfleur
ZIP/Postal Code
76700
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
C.H. General Andre Boulloche
City
Montbeliard
ZIP/Postal Code
25209
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique Saint - Pierre
City
Perpignan
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieux
ZIP/Postal Code
F-22015
Country
France
Facility Name
Polyclinique de L'Ormeau
City
Tarbes
ZIP/Postal Code
65000
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Hopital J. Ducuing
City
Toulouse
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

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

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