Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery

NCT00381901 | Completed Phase 3

• 4 other identifiers: CDR0000509793INCA-PHAREINCA-RECF0146EUDRACT-2006-000070-67
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 82

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer. PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IA breast cancer; stage IB breast cancer; recurrent breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Time to recurrence

Secondary Outcomes (3)

• Cardiotoxicity as measured by LVEF

• Distant metastasis-free survival

• Overall survival

Interventions

trastuzumab BIOLOGICAL

polymorphism analysis GENETIC

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Nonmetastatic disease * Positive or negative axillary nodes * Tumor size ≥ 10 mm * Resectable disease * Must have received ≥ 4 courses of chemotherapy for this disease * A 12-month adjuvant treatment with trastuzumab (Herceptin®) has been initiated * Informed consent form must be signed between the third and sixth months of trastuzumab therapy * Overexpression of HER-2 in the invasive component of the primary tumor as indicated by 1 of the following: * 3+ by immunohistochemistry (IHC) * 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * LVEF considered favorable for continuing trastuzumab treatment as measured by echocardiography or MUGA at 2-4 months after beginning adjuvant trastuzumab * No serious cardiac illness or medical condition precluding trastuzumab treatment, including any of the following: * History of documented congestive heart failure * High-risk uncontrolled arrhythmias * Angina pectoris requiring antianginal medication * Severe dyspnea at rest or oxygen-dependent * No known hypersensitivity to trastuzumab, murine proteins, or any of the excipients * Not pregnant or nursing * No social, geographical, or psychological condition that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Other prior anti-HER-2 therapy allowed * No prior trastuzumab other than initiation of trastuzumab adjuvant therapy

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

Sponsors & Collaborators

• National Cancer Institute, France: lead

Study Sites (82)

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Centre Hospitalier La Fontonne

Antibes, 06600, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre Hospital General Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

C.H.U. de Brest

Brest, 29200, France

Location

Centre Hospitalier General

Brivé, 19101, France

Location

Centre Hospitalier William Morey

Chalon-sur-Saône, 71100, France

Location

Clinique Notre Dame du Bon Secours

Chartres, 28000, France

Location

Hopital Louis Pasteur

Chartres, 28018, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier de Dax

Dax, 40100, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Hopital Jean Monnet

Épinal, 88021, France

Location

Hopital Clarac

Fort de France Cedex, 97261, France

Location

Institut Prive de Cancerologie

Grenoble, 38100, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Centre De Radiotherapie Charlebourg

La Garenne-Colombes, 92250, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, 85025, France

Location

Centre Hospitalier de Lagny

Lagny-sur-Marne, 77405, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Institut d'Oncologie Hartmann

Levallois-Perret, 92300, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Clinique Chenieux

Limoges, 87000, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Medical Parot

Lyon, 69006, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, 77100, France

Location

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

Marseille, 13273, France

Location

Hopital Clinique Claude Bernard

Metz, 57072, France

Location

Centre de Radiologie et de Traitement des Tumeurs

Meudon-la-Forêt, 92360, France

Location

CH Meulan

Meulan-en-Yvelines, 78250, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Hospitalier de Montelimar

Montélimar, 26200, France

Location

Centre Hospitalier de Montlucon

Montluçon, 03109, France

Location

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

Montpellier, 34298, France

Location

Clinique Clementville

Montpellier, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Centre Catherine de Sienne

Nantes, 02, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint-Herblain, 44805, France

Location

Clinique Les Genets

Narbonne, 11100, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Clinique Belvedere

Nice, 06000, France

Location

Clinique Saint George

Nice, 06100, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

Nîmes, 30029, France

Location

Clinique De Valdegour

Nîmes, 30900, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Hospitalier - Pau

Pau, 64046, France

Location

Clinique Saint - Pierre

Perpignan, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Intercommunal de Poissy

Poissy, 78300, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CHG Roanne

Roanne, F-42300, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Etienne Dolet

Saint-Nazaire, 44600, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Clinique Sainte Clotilde

Sainte Clotilde, 97192, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

Toulon, 83056, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Related Publications (7)

• Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espie M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Venat-Bouvet L, Cany L, Catala S, Khayat D, Gambotti L, Pauporte I, Faure-Mercier C, Paget-Bailly S, Henriques J, Grouin JM; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial. Lancet. 2019 Jun 29;393(10191):2591-2598. doi: 10.1016/S0140-6736(19)30653-1. Epub 2019 Jun 6.

  PMID: 31178155 DERIVED

• Jacquinot Q, Paget-Bailly S, Fumoleau P, Romieu G, Pierga JY, Espie M, Lortholary A, Nabholtz JM, Mercier CF, Pauporte I, Henriques J, Pivot X. Fluctuation of the left ventricular ejection fraction in patients with HER2-positive early breast cancer treated by 12 months of adjuvant trastuzumab. Breast. 2018 Oct;41:1-7. doi: 10.1016/j.breast.2018.06.001. Epub 2018 Jun 15.

  PMID: 29913374 DERIVED

• Curtit E, Pivot X, Henriques J, Paget-Bailly S, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulie P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Levy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Kerbrat P, Faure-Mercier C, Blanche H, Sahbatou M, Boland A, Bacq D, Besse C, Thomas G, Deleuze JF, Pauporte I, Romieu G, Cox DG. Assessment of the prognostic role of a 94-single nucleotide polymorphisms risk score in early breast cancer in the SIGNAL/PHARE prospective cohort: no correlation with clinico-pathological characteristics and outcomes. Breast Cancer Res. 2017 Aug 22;19(1):98. doi: 10.1186/s13058-017-0888-4.

  PMID: 28830573 DERIVED

• Pivot X, Fumoleau P, Pierga JY, Delaloge S, Bonnefoi H, Bachelot T, Jouannaud C, Bourgeois H, Rios M, Soulie P, Jacquin JP, Lavau-Denes S, Kerbrat P, Cox D, Faure-Mercier C, Pauporte I, Gligorov J, Curtit E, Henriques J, Paget-Bailly S, Romieu G. Superimposable outcomes for sequential and concomitant administration of adjuvant trastuzumab in HER2-positive breast cancer: Results from the SIGNAL/PHARE prospective cohort. Eur J Cancer. 2017 Aug;81:151-160. doi: 10.1016/j.ejca.2017.05.020. Epub 2017 Jun 16.

  PMID: 28624696 DERIVED

• Pivot X, Suter T, Nabholtz JM, Pierga JY, Espie M, Lortholary A, Khayat D, Pauporte I, Romieu G, Kramar A, Fumoleau P. Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study. Eur J Cancer. 2015 Sep;51(13):1660-6. doi: 10.1016/j.ejca.2015.05.028. Epub 2015 Jul 7.

  PMID: 26163096 DERIVED

• Kramar A, Bachelot T, Madrange N, Pierga JY, Kerbrat P, Espie M, Fumoleau P, Pauporte I, Khayat D, Romieu G, Pivot X. Trastuzumab duration effects within patient prognostic subgroups in the PHARE trial. Ann Oncol. 2014 Aug;25(8):1563-70. doi: 10.1093/annonc/mdu177. Epub 2014 May 14.

  PMID: 24827132 DERIVED

• Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espie M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporte I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

  PMID: 23764181 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Amplified Fragment Length Polymorphism Analysis; Chemotherapy, Adjuvant

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; DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Xavier Pivot, MD, PhD

  Hopital Jean Minjoz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2009-07

Locations

FR (82)