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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00053911
• Other study ID #: PACS03
• Secondary ID: FRE-FNCLCC-PACS-
• Status: Terminated
• Phase: Phase 3
• First received: February 5, 2003
• Last updated: December 14, 2014
• Start date: November 2002

Study information

• Verified date: December 2014
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• anastrozole

• cyclophosphamide

• docetaxel

• epirubicin hydrochloride

• fluorouracil

• goserelin acetate

• tamoxifen citrate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
France	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	Brive
France	Centre Regional Francois Baclesse	Caen
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Hospitalier Compiegne	Compiegne
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	Montbeliard
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	Hopital J. Ducuing	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the disease free survival		5 years	No
Secondary	Evaluation of the overall survival		5 years	No