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Phase III Randomized Study of Adjuvant Trastuzumab (Herceptin®) Administered for 6 Months Versus 12 Months in Women With Nonmetastatic, Resectable Breast Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Treatment | Active | 18 and over | INCA-PHARE PHARE, INCA-RECF0146, EUDRACT-2006-000070-67, NCT00381901 |
Objectives 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.
Entry Criteria 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
Prior/Concurrent Therapy:
- See Disease Characteristics
- Other prior anti-HER-2 therapy allowed
- No prior trastuzumab other than initiation of trastuzumab adjuvant therapy
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
Expected Enrollment 7000A total of 7,000 patients will be accrued for this study. Outcomes Primary Outcome(s)Time to recurrence
Secondary Outcome(s)Cardiotoxicity as measured by LVEF Distant metastasis-free survival Overall survival
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. Some patients undergo blood collection for HER-2 polymorphism analysis.
After completion of study therapy, patients are followed periodically for approximately 5 years.
Trial Contact Information
Trial Lead Organizations Institut National du Cancer | | | Xavier Pivot, MD, PhD, Protocol chair | | | | Trial Sites
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France |
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Angers |
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| | | Centre Paul Papin |
| | Sophie Abadie-Lacourtoisie, MD | |
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Annecy |
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| | Centre Hospitalier d'Annecy |
| | Jocelyne Provencal, MD | |
| Email:
jprovencal@ch-annecy.fr |
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Antibes |
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| | Centre Hospitalier La Fontonne |
| | Jean-Francois Dor, MD | |
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Argenteuil |
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| | Centre Hospitalier Victor Dupouy |
| | Marine Gross-Goupil, MD | |
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Aulnay Sous Bois |
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| | Centre Hospital General Robert Ballanger |
| | Ghania Sadki-Benaoudia, MD | |
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Avignon |
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| | Institut Sainte Catherine |
| | Daniel Serin, MD | |
| Email:
d.serin@isc84.org |
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Beauvais |
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| | C.H.G. Beauvais |
| | Suzanne Nguyen, MD | |
| Email:
s.nguyen@ch-beauvais.fr |
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Besancon |
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| | Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
| | Xavier Pivot, MD, PhD | |
| Email:
xpivot@chu-besancon.fr |
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Bobigny |
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| | Hopital Avicenne |
| | Jean-Luc Breau, MD, PhD | |
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Bordeaux |
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| | Clinique Tivoli |
| | Dominique Jaubert, MD | |
| Email:
dominique.jaubert@wanadoo.fr |
| | Institut Bergonie |
| | Louis Mauriac, MD | |
| Email:
mauriac@bergonie.org |
| | Polyclinique Bordeaux Nord Aquitaine |
| | Nadine Dohollou, MD | |
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Boulogne Sur Mer |
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| | Centre Hospitalier Docteur Duchenne |
| | Zoher Merad-Boudia | |
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Brest |
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| | C.H.U. de Brest |
| | Nacr-Eddine Achour, MD | |
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Brive |
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| | Centre Hospitalier General |
| | Bernard Leduc, MD | |
| Email:
oncologie@ch-brive.fr |
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Chalon-sur-Saone |
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| | Centre Hospitalier William Morey |
| | Bruno Salles, MD | |
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Chartres |
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| | Clinique Notre Dame du Bon Secours |
| | Marie Gasowski, MD | |
| | Hopital Louis Pasteur |
| | Elizabeth Angellier, MD, PhD | |
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Clamart |
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| | Hopital Antoine Beclere |
| | Francois Boue, MD, PhD | |
| Email:
francois.boue@abc.ap-hop-paris.fr |
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Clermont-Ferrand |
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| | Centre Jean Perrin |
| | Philippe Chollet, MD, PhD | |
| Email:
philippe.chollet@cjp.fr |
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Colmar |
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| | Hopital Louis Pasteur |
| | Bruno Audhuy, MD | |
| Email:
bruno.audhuy@ch-colmar.rss.fr |
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Dax |
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| | Centre Hospitalier de Dax |
| | Laure Gautier-Felizot | |
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Dijon |
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| | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
| | Pierre Fumoleau, MD, PhD | |
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Epinal |
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| | Hopital Jean Monnet |
| | Stephane Ruck, MD | |
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Fort de France Cedex |
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| | Hopital Clarac |
| | Patrick Escarmant, MD | |
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Grenoble |
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| | Institut Prive de Cancerologie |
| | David Coeffic, MD | |
| Email:
dcoeffic@club-internet.fr |
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Hyeres |
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| | Clinique Sainte-Marguerite |
| | Jean-Louis Wendling, MD | |
| Email:
jlwendling@aol.com |
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La Garenne Colombes |
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| | Centre De Radiotherapie Charlebourg |
| | Gerard Auclerc, MD | |
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La Roche Sur Yon |
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| | Centre Hospitalier Departemental |
| | Franck Priou, MD | |
| Email:
frank.priou@chd-vendee.fr |
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Lagny Sur Marne |
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| | Centre Hospitalier de Lagny |
| | Caroline Toussaint-Batbedat, MD | |
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Le Chesnay |
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| | Hopital Andre Mignot |
| | Didier Mayeur, MD | |
| Email:
dmayeur@ch-versailles.fr |
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Le Mans |
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| | Clinique Victor Hugo |
| | Gerard Ganem, MD | |
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Levallois-Perret |
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| | Institut d'Oncologie Hartmann |
| | Jean Francois Llory, MD | |
| Email:
jfllory@i-o-h.org |
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Libourne |
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| | Hopital Robert Boulin |
| | Nathalie Trufflandier, MD | |
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Limoges |
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| | Centre Hospital Regional Universitaire de Limoges |
| | Nicole Tubiana-Mathieu, MD | |
| Email:
oncologie@chu-limoges.fr |
| | Clinique Chenieux |
| | Xavier-Francois Zasadny, MD | |
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Lyon |
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| | Centre Leon Berard |
| | Jean Paul Guastalla, MD, PhD | |
| Email:
guastall@lyon.fnclcc.fr |
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LYON |
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| | Centre Medical Parot |
| | Alain Voloch, MD | |
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Lyon |
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| Hopital Edouard Herriot - Lyon |
| | Jean-Yves Blay, MD, PhD | |
| Email:
jy.blay@chu-lyon.fr |
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Mareuil Les Meaux |
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| | Centre de Radiotherapie et Oncologie Saint-Faron |
| | Jacques Mandet, MD | |
| Email:
jacques.mandet@wanadoo.fr |
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Marseille |
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| | Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes |
| | Carole Tarpin, MD | |
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Metz |
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| | Hopital Clinique Claude Bernard |
| | Emmanuel Achille, MD | |
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Meudon La Foret |
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| | Centre de Radiologie et de Traitement des Tumeurs |
| | Eric Chirat, MD | |
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Meulan |
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| | CH Meulan |
| | Patricia Amsalhem, MD | |
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Mont-de-Marsan |
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| | Centre Hospitalier General de Mont de Marsan |
| | Jerome Dauba | |
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Montelimar |
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| | Centre Hospitalier de Montelimar |
| | Bertrand Mongodin, MD | |
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Montlucon |
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| | Centre Hospitalier de Montlucon |
| | Marie-Agnes Bichoffe, MD | |
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Montpellier |
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| | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
| | Gilles Romieu, MD | |
| | Clinique Clementville |
| | Stephane Jacquot, MD | |
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Mougins |
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| | Centre Azureen de Cancerologie |
| | Moise Namer, MD, PhD | |
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Nantes |
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| | Centre Catherine de Sienne |
| | Alain Lortholary, MD | |
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Nantes-Saint-Herblain |
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| | Centre Regional Rene Gauducheau |
| | Mario Campone, MD | |
| Email:
m-campone@nantes-fnclcc.fr |
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Narbonne |
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| | Clinique Les Genets |
| | Andre Mathieu, MD | |
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Neuilly sur Seine |
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| | Clinique Hartmann |
| | Eric-Charles Antoine, MD | |
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Nice |
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| | Centre Antoine Lacassagne |
| | Jean Marc Ferrero, MD | |
| Email:
jean-marc.ferrerero@nice.fnclcc.fr |
| | Clinique Belvedere |
| | Gerard Lesbats, MD | |
| | Clinique Saint George |
| | Michel Hoch | |
| Email:
michel.hoch@wanadoo.fr |
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Nimes |
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| | C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau |
| | Francois Bons, MD | |
| | Clinique De Valdegour |
| | Jacques Cretin, MD | |
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Paris |
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| | CHU Pitie-Salpetriere |
| | David Khayat, MD, PhD | |
| Email:
david.khayat@psl.aphp.fr |
| | Hopital Europeen Georges Pompidou |
| | Eric Levy, MD | |
| | Hopital Saint-Louis |
| | Marc Espie, MD | |
| | Institut Curie Hopital |
| | Jean-Yves Pierga, MD, PhD | |
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Pau |
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| | Centre Hospitalier - Pau |
| | Nathalie Quenel-Tueux, MD | |
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Perigueux |
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| | Polyclinique Francheville |
| | Laurent Cany, MD | |
| Email:
l.cany@oncoradio24.com |
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Perpignan |
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| | Clinique Saint - Pierre |
| | Stephanie Catala, MD | |
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Pierre Benite |
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| | Centre Hospitalier Lyon Sud |
| | Veronique Trillet-Lenoir, MD | |
| Email:
veronique.trillet-lenoir@chu-lyon.fr |
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Poissy |
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| | Centre Hospitalier Intercommunal de Poissy |
| | Philippe Soyer, MD | |
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Poitiers |
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| | Hopital Jean Bernard |
| | Jean-Marc Tourani, MD | |
| Email:
jm.tourani@chu.poitiers.frs.fr |
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Reims |
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| | Institut Jean Godinot |
| | Christelle Jouannaud, MD | |
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Rennes |
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| | Centre Eugene Marquis |
| | Pierre Kerbrat, MD, PhD | |
| Email:
kerbrat@rennes.fnclcc.fr |
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Roanne |
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| | CHG Roanne |
| | Lionel Vincent, MD | |
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Rouen |
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| | Centre Henri Becquerel |
| | Emmanuel Blot, MD, PhD | |
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Saint Brieuc |
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| | Clinique Armoricaine De Radiologie |
| | Anne-Claire Hardy-Bessard, MD | |
| Email:
ac.hardy@clin-armoricaine.fr |
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Saint Priest en Jarez |
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| | Institut de Cancerologie de la Loire |
| | Guillaume Clavreul, MD | |
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Sainte Clotilde |
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| | Clinique Sainte Clotilde |
| | Mickael Begue, MD | |
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Saint-Nazaire |
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| | Centre Etienne Dolet |
| | Valarie Delecroix, MD | |
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Strasbourg |
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| | Centre Paul Strauss |
| | Thierry Petit, MD, PhD | |
| Email:
tpetit@strasbourg.fnclcc.fr |
| | Clinique de l'Orangerie |
| | Francois Schaeffer, MD | |
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Toulon - Cedex |
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| | Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer |
| | Laurent Cals, MD | |
| Email:
Laurent.Cals@ch.toulon.fr |
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Toulouse |
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| | Institut Claudius Regaud |
| | Florence Dalenc, MD | |
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Tours |
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| | Centre Hospitalier Universitaire Bretonneau de Tours |
| | Philippe Bougnoux, MD, PhD | |
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Registry Information | | Official Title | | Protocol of Herceptin® Adjuvant with Reduced Exposure, a Randomised Comparison of 6 Months vs 12 months in all Women Receiving Adjuvant Herceptin® [PHARE] | | Trial Start Date | | 2006-05-30 | | Registered in ClinicalTrials.gov | | NCT00381901 | | Date Submitted to PDQ | | 2006-09-13 | | Information Last Verified | | 2008-12-28 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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