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Breast CancerPhase 3NCT00054587

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

A Phase 3 study testing Trastuzumab, Cyclophosphamide and docetaxel in people with Breast Cancer, run by UNICANCER at 29 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 to 64 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab, Cyclophosphamide and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,010 participants
Where
29 sitesFrance
Study dates
Jun 2001to Dec 2009
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 64 years
  • Women only
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
  • Axillary lymph node invasion (N1, N2, or N3)
  • No cutaneous invasion
  • No T4a or greater disease
  • No clinically or radiologically suspected metastases
  • No clinically or radiologically suspected contralateral lesion
  • No deeply adherent or inflammatory disease
  • Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days
  • No prior breast cancer
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

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

  • ALT and AST no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin no greater than ULN
  • Hepatitis B and hepatitis C negative
  • No hepatic dysfunction

Renal

  • Creatinine less than 1.3 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • ECHO normal
  • LVEF at least 50%

Pulmonary

  • FEV normal
  • No dyspnea at rest
  • No supplemental oxygen dependence

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to anthracycline therapy
  • No chronic medical or psychological condition
  • No geographic or social reason that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No other concurrent chemotherapy
  • No contraindication to anthracycline therapy

Endocrine therapy

  • No prior hormonal therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 4 weeks since prior experimental therapy

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Institut Bergonie

    Bordeaux, 33076

  • C.H. Bourg En Bresse

    Bourg-en-Bresse, 01012

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Intercommunal De Creteil

    Créteil, 94010

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Institut Prive de Cancerologie

    Grenoble, 38100

  • Clinique du Petit Colmouilins

    Harfleur, 76700

  • Centre Hospitalier de Lagny

    Lagny-sur-Marne, 77405

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • CMC Les Ormeaux

    Le Havre, 76600

  • Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Centre Hospitalier Regional Metz Thionville

    Metz, 57038

  • Centre Hospitalier General Andre Boulloche

    Montbéliard, 25209

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Hopital Avicenne

    Paris, 75674

  • Clinique Saint - Pierre

    Perpignan

  • CHU Poitiers

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Clinique Sainte Clotilde

    Sainte Clotilde, 97492

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
  • Determine survival of patients treated with these regimens.
  • Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
  • Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
  • Evaluate the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.

  • Part I: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
  • Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I.

Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.

Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.

  • Part II: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.
  • Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.

Conditions
Breast Cancer
Keywords
stage II breast cancer, stage IIIA 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.

  • TrastuzumabBiological

    Also called Herceptin

    8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)

  • CyclophosphamideDrug

    500 mg/m², D1 and every 3 weeks

  • docetaxelDrug

    on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks

  • EpirubicinDrug

    Also called epirubicin hydrochloride

    100 mg/m², D1 and every 3 weeks

  • FluorouracilDrug

    500 mg/m², D1 and every 3 weeks

Study groups in NCT00054587
Study groupRoleWhat they receive
6 FECActive comparatorPatients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
Receives: Biological: Trastuzumab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Fluorouracil
6 DEExperimentalPatients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I
Receives: Biological: Trastuzumab; Drug: docetaxel; Drug: Epirubicin

What is being measured

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

  1. Progression Free Survival

    Measured: 5 years from randomization

Secondary outcomes (2)

  1. Herceptin safety

    Measured: 5 years from randomization

  2. Overall 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 posted6 Feb 2003 (estimated)
  2. Study startJun 2001
  3. Primary completionJun 2009
  4. Study completionDec 2009

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
3,010 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054587
Sponsor's protocol ID
UC-0140/0005 - PACS 04
Other IDs
FRE-FNCLCC-PACS-04/0005, EU-20236, PACS04
Status last verified
Jul 2013
First submitted
5 Feb 2003
Last updated
19 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Mancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C. Transparency in the presentation of trial results may not increase patients' trust in medical researchers. Clin Trials. 2012 Feb;9(1):90-3. doi: 10.1177/1740774511427063. Epub 2011 Nov 2.

    PubMed 22049088

  • Roché H, Allouache D, Romieu G, et al.: Five-year analysis of the FNCLCC-PACS04 trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-602, 2009.

  • Spielmann M, Roche H, Delozier T, Canon JL, Romieu G, Bourgeois H, Extra JM, Serin D, Kerbrat P, Machiels JP, Lortholary A, Orfeuvre H, Campone M, Hardy-Bessard AC, Coudert B, Maerevoet M, Piot G, Kramar A, Martin AL, Penault-Llorca F. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16.

    PubMed 19917839

  • Spielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.

  • Spielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.

  • O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.

    PubMed 26101239

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab, Cyclophosphamide and docetaxel in people with Breast Cancer, run by UNICANCER at 29 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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?

Progression Free 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 NCT00054587, which also lists 6 linked publications.

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 19 Jul 2013.

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