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

Breast Cancer Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381901
• Other study ID #: CDR0000509793
• Secondary ID: INCA-PHAREINCA-R
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2006
• Last updated: May 12, 2011
• Start date: May 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3400
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• trastuzumab

Genetic:
• polymorphism analysis

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
France	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	Besancon
France	Hopital Avicenne	Bobigny
France	Clinique Tivoli	Bordeaux
France	Institut Bergonie	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre Hospitalier Docteur Duchenne	Boulogne Sur Mer
France	C.H.U. de Brest	Brest
France	Centre Hospitalier General	Brive
France	Centre Hospitalier William Morey	Chalon-sur-Saone
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	Epinal
France	Hopital Clarac	Fort de France Cedex
France	Institut Prive de Cancerologie	Grenoble
France	Clinique Sainte-Marguerite	Hyeres
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	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Clinique Chenieux	Limoges
France	Centre Leon Berard	Lyon
France	Centre Medical Parot	Lyon
France	Hopital Edouard Herriot - Lyon	Lyon
France	Centre de Radiotherapie et Oncologie Saint-Faron	Mareuil Les 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 Foret
France	CH Meulan	Meulan
France	Centre Hospitalier General de Mont de Marsan	Mont-de-Marsan
France	Centre Hospitalier de Montelimar	Montelimar
France	Centre Hospitalier de Montlucon	Montlucon
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	Centre Antoine Lacassagne	Nice
France	Clinique Belvedere	Nice
France	Clinique Saint George	Nice
France	C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau	Nimes
France	Clinique De Valdegour	Nimes
France	CHU Pitie-Salpetriere	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint-Louis	Paris
France	Institut Curie Hopital	Paris
France	Centre Hospitalier - Pau	Pau
France	Polyclinique Francheville	Perigueux
France	Clinique Saint - Pierre	Perpignan
France	Centre Hospitalier Lyon Sud	Pierre Benite
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	Institut de Cancerologie de la Loire	Saint Priest en Jarez
France	Centre Etienne Dolet	Saint-Nazaire
France	Clinique Sainte Clotilde	Sainte Clotilde
France	Centre Paul Strauss	Strasbourg
France	Clinique de l'Orangerie	Strasbourg
France	Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer	Toulon - Cedex
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence			No
Secondary	Cardiotoxicity as measured by LVEF			Yes
Secondary	Distant metastasis-free survival			No
Secondary	Overall survival			No