Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery
NCT ID: NCT00381901
Last Updated: 2011-05-13
Study Results
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Basic Information
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COMPLETED
PHASE3
3400 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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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.
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Detailed Description
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Primary
* Compare the disease-free survival of women with nonmetastatic, resectable breast cancer treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months.
Secondary
* Compare cardiotoxicity in patients receiving these regimens.
* Compare the cardiotoxicity and disease-free survival of patients receiving concurrent trastuzumab and chemotherapy vs sequential administration.
* Correlate HER-2 polymorphism with disease-free survival/cardiotoxicity in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, modality of adjuvant chemotherapy (concurrent vs sequential), and adjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I (control arm, 12-month therapy): Patients continue to receive trastuzumab (Herceptin®) IV until a total of 12 months of therapy is completed in the absence of disease progression or unacceptable toxicity.
* Arm II (experimental arm, 6-month therapy): Patients continue to receive trastuzumab\* IV until a total of 6 months of therapy is completed in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients who have already finished 6 months of trastuzumab at randomization do not receive further trastuzumab.
Some patients undergo blood collection for HER-2 polymorphism analysis.
After completion of study therapy, patients are followed periodically for approximately 5 years.
PROJECTED ACCRUAL: A total of 7,000 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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trastuzumab
polymorphism analysis
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Principal Investigators
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Xavier Pivot, MD, PhD
Role: STUDY_CHAIR
Hopital Jean Minjoz
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier d'Annecy
Annecy, , France
Centre Hospitalier La Fontonne
Antibes, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Centre Hospital General Robert Ballanger
Aulnay-sous-Bois, , France
Institut Sainte Catherine
Avignon, , France
C.H.G. Beauvais
Beauvais, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Hopital Avicenne
Bobigny, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
C.H.U. de Brest
Brest, , France
Centre Hospitalier General
Brivé, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
Clinique Notre Dame du Bon Secours
Chartres, , France
Hopital Louis Pasteur
Chartres, , France
Hopital Antoine Beclere
Clamart, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier de Dax
Dax, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Hopital Jean Monnet
Épinal, , France
Hopital Clarac
Fort de France Cedex, , France
Institut Prive de Cancerologie
Grenoble, , France
Clinique Sainte-Marguerite
Hyères, , France
Centre De Radiotherapie Charlebourg
La Garenne-Colombes, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Hospitalier de Lagny
Lagny-sur-Marne, , France
Hopital Andre Mignot
Le Chesnay, , France
Clinique Victor Hugo
Le Mans, , France
Institut d'Oncologie Hartmann
Levallois-Perret, , France
Hopital Robert Boulin
Libourne, , France
Clinique Chenieux
Limoges, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Medical Parot
Lyon, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-lès-Meaux, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Hopital Clinique Claude Bernard
Metz, , France
Centre de Radiologie et de Traitement des Tumeurs
Meudon-la-Forêt, , France
CH Meulan
Meulan-en-Yvelines, , France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Centre Hospitalier de Montelimar
Montélimar, , France
Centre Hospitalier de Montlucon
Montluçon, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Clinique Clementville
Montpellier, , France
Centre Azureen de Cancerologie
Mougins, , France
Centre Catherine de Sienne
Nantes, , France
Centre Regional Rene Gauducheau
Nantes-Saint-Herblain, , France
Clinique Les Genets
Narbonne, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
Clinique Belvedere
Nice, , France
Clinique Saint George
Nice, , France
Centre Antoine Lacassagne
Nice, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, , France
Clinique De Valdegour
Nîmes, , France
Hopital Europeen Georges Pompidou
Paris, , France
Institut Curie Hopital
Paris, , France
Hopital Saint-Louis
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Centre Hospitalier - Pau
Pau, , France
Clinique Saint - Pierre
Perpignan, , France
Polyclinique Francheville
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Intercommunal de Poissy
Poissy, , France
Hopital Jean Bernard
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
CHG Roanne
Roanne, , France
Centre Henri Becquerel
Rouen, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Etienne Dolet
Saint-Nazaire, , France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, , France
Clinique Sainte Clotilde
Sainte Clotilde, , France
Clinique de l'Orangerie
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
Toulon, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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INCA-PHARE
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0146
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2006-000070-67
Identifier Type: -
Identifier Source: secondary_id
CDR0000509793
Identifier Type: -
Identifier Source: org_study_id
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