AzTrials
AzTrials

Breast CancerPhase 3NCT00055679

Combination Chemotherapy in Treating Women With Stage I Breast Cancer

A Phase 3 study testing cyclophosphamide, epirubicin hydrochloride and fluorouracil in people with Breast Cancer, run by UNICANCER at 72 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
cyclophosphamide, epirubicin hydrochloride and fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,512 participants
Where
72 sitesFrance
Study dates
Aug 2002to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
  • Stage I
  • No clinically or radiologically suspicious metastases
  • No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm
  • No clinically proven positive axillary lymph nodes
  • Tumor cells found on immunohistochemistry only allowed
  • No clinically or radiologically contralateral suspicious lesions
  • No deeply adherent disease
  • No cutaneous invasion
  • No inflammatory disease
  • Complete surgical resection within the past 42 days
  • At least 8 lymph nodes removed
  • Tumor at least 1 cm with no residual disease
  • Presenting with at least 1 of the following factors of a poor prognosis:
  • Tumor greater than 2 cm
  • Hormone receptor negative tumor
  • Grade II or III
  • 35 years old or under
  • Hormone receptor status:
  • Positive or negative

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST and ALT no greater than 1.25 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No chronic hepatitis B
  • No active hepatitis C

Renal

  • Creatinine no greater than 1.25 times ULN

Pulmonary

  • FEV normal

Other

  • Not pregnant or nursing
  • HIV negative
  • No prior breast cancer or other malignancy
  • No familial, social, or geographical reason that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No prior anticancer hormone therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

France72 sites

  • Clinique Claude Bernard

    Albi, 81000

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • Centre Hospital General Robert Ballanger

    Aulnay-sous-Bois, 93602

  • Centre Hospitalier d'Auxerre

    Auxerre, 89011

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • C.H.G. Beauvais

    Beauvais, 60021

  • Centre Hospitalier General

    Belfort, 90000

  • Institut Bergonie

    Bordeaux, 33076

  • Clinique Tivoli

    Bordeaux, F-33000

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • Centre Hospitalier de Fleyriat

    Bourg-en-Bresse, 01012

  • Centre Hospitalier Jacques-Coeur

    Bourges, 18016

  • CHU Hopital A. Morvan

    Brest, 29609

  • Centre Hospitalier General

    Brivé, 19101

  • Polyclinique Du Parc Centre Maurice Tubiana

    Caen, 14052

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Regional de Chambery

    Chambéry, 73011

  • Clinique Prive Paul d'Egine

    Champigny-sur-Marne, 94500

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur

    Colmar, 68024

  • Clinique des Cedres

    Cornebarrieu, 31700

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier Draguignan

    Draguignan, 83300

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Institut Prive de Cancerologie

    Grenoble, 38100

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, 85025

  • Centre Hospitalier de Lagny

    Lagny-sur-Marne, 77405

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospitalier Bretagne Sud

    Lorient, 56322

  • Hopital Hotel Dieu

    Lyon, 69288

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot

    Lyon, 69437

  • Centre de Radiotherapie et Oncologie Saint-Faron

    Mareuil-lès-Meaux, 77100

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Centre Hospitalier General Andre Boulloche

    Montbéliard, 25209

  • Intercommunal Hospital

    Montfermeil, 93370

  • Centre Azureen de Cancerologie

    Mougins, 06250

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Clinique D'Occitanie

    Muret, 31600

  • Centre Catherine de Sienne

    Nantes, 02

  • Centre Regional Rene Gauducheau

    Nantes-Saint-Herblain, 44805

  • Clinique Les Genets

    Narbonne, 11100

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • C.H.G. De Pau

    Pau, 64046 Universite Cedex

  • Polyclinique Francheville

    Périgueux, 24004

  • Clinique Saint - Pierre

    Perpignan

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Poitiers

    Poitiers, 86021

  • Centre Hospitalier de Cornouaille

    Quimper, 29107

  • Centre Eugene Marquis

    Rennes, 35042

  • CHG Roanne

    Roanne, F-42300

  • Centre Hospitalier de Rodez

    Rodez, 12027

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Centre Paul Strauss

    Strasbourg, 67065

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Polyclinique de L'Ormeau

    Tarbes, 65000

  • Institut Claudius Regaud

    Toulouse, 31052

  • Clinique Pasteur

    Toulouse, 31076

  • Clinique Du Parc

    Toulouse, 31078

  • Clinique du Chateau

    Toulouse, 31080

  • Hopital J. Ducuing

    Toulouse

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
  • Compare the toxicity of these regimens in these patients.
  • Determine the correlation of length of survival with biological factors in patients treated with these regimens.
  • Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens.
  • Determine the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks. Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years, beginning after completion of chemotherapy.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for this study within 3 years.

Conditions
Breast Cancer
Being tested
cyclophosphamide, epirubicin hydrochloride, fluorouracil
Keywords
stage I breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00055679
Study groupRoleWhat they receive
6 FECActive comparator6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
Receives: Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil
4 FECExperimental4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
Receives: Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy, in terms of 5-year survival

    Measured: 5 years from randomization

Secondary outcomes (3)

  1. Event free survival

    Measured: 5 years from randomization

  2. Toxicity

    Measured: 5 years from randomization

  3. Biological factors significant for prognosis and prediction of survival

    Measured: 5 years from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionJun 2012
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055679
Sponsor's protocol ID
PACS05 UC-0140-0106
Other IDs
FRE-FNCLCC-PACS-05/0106, EU-20239
Status last verified
Jun 2013
First submitted
6 Mar 2003
Last updated
18 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Kerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain E, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roche H. Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106). Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11.

    PubMed 28501763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, epirubicin hydrochloride and fluorouracil in people with Breast Cancer, run by UNICANCER at 72 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy, in terms of 5-year survival (time frame: 5 years from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055679, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.

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