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

NCT00054587 | Completed Phase 3 DMC

• 4 other identifiers: UC-0140/0005 - PACS 04FRE-FNCLCC-PACS-04/0005EU-20236PACS04
• Study Type: interventional
• Target: 3,010
• Locations: 1 country
• Sites: 29

Brief 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. 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).

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  5 years from randomization

Secondary Outcomes (2)

• Herceptin safety

  5 years from randomization

• Overall survival

  5 years from randomization

Study Arms (2)

6 FEC

ACTIVE COMPARATOR

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.

Biological: Trastuzumab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Fluorouracil

6 DE

EXPERIMENTAL

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

Biological: Trastuzumab; Drug: docetaxel; Drug: Epirubicin

Interventions

Trastuzumab BIOLOGICAL

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)

Also known as: Herceptin

6 DE; 6 FEC

Cyclophosphamide DRUG

500 mg/m², D1 and every 3 weeks

6 FEC

docetaxel DRUG

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

6 DE

Epirubicin DRUG

100 mg/m², D1 and every 3 weeks

Also known as: epirubicin hydrochloride

6 DE; 6 FEC

Fluorouracil DRUG

500 mg/m², D1 and every 3 weeks

6 FEC

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (29)

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Institut Prive de Cancerologie

Grenoble, 38100, France

Location

Clinique du Petit Colmouilins

Harfleur, 76700, France

Location

Centre Hospitalier de Lagny

Lagny-sur-Marne, 77405, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

CMC Les Ormeaux

Le Havre, 76600, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Hospitalier Regional Metz Thionville

Metz, 57038, France

Location

Centre Hospitalier General Andre Boulloche

Montbéliard, 25209, France

Location

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

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Hopital Avicenne

Paris, 75674, France

Location

Clinique Saint - Pierre

Perpignan, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Clinique Sainte Clotilde

Sainte Clotilde, 97492, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (6)

• 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.

  PMID: 22049088 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 19917839 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 26101239 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marc Spielmann, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: June 1, 2001
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

FR (29)