A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years
NCT ID: NCT01810393
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2013-06-11
2019-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Trastuzumab IV Then Trastuzumab SC
Participants will receive treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Trastuzumab
Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
Trastuzumab SC Then Trastuzumab IV
Participants will receive treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Trastuzumab
Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
Interventions
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Trastuzumab
Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
* Left ventricular ejection fraction (LVEF) of greater than or equal to (\>/=) 50 percent (%)
* Hormonal therapy will be allowed
* Prior use of anti-HER2 therapy will be allowed
Exclusion Criteria
* Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
* Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
* Hepatitis B, hepatitis C or human immunodeficiency virus infection
* Pregnant or lactating women
* Concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
* Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma
* Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
* Inadequate organ function
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Clinique Du Docteur Calabet; Cromg
Agen, , France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, , France
ICO Paul Papin; Oncologie Medicale.
Angers, , France
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, , France
Institut Sainte-Catherine; Oncologie
Avignon, , France
Centre Hospitalier de La Cote Basque; Oncologie
Bayonne, , France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, , France
Institut Bergonie
Bordeaux, , France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, , France
Hopital Morvan
Brest, , France
Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
Brest, , France
Centre Francois Baclesse; Oncologie
Caen, , France
Centre Jean Perrin; Oncologie
Clermont-Ferrand, , France
Pole Sante Republique;Oncologie Hematologie
Clermont-Ferrand, , France
Chi De Creteil; Radiotherapie Oncologie
Créteil, , France
Centre Leonard De Vinci;Chimiotherapie
Dechy, , France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
Ch Louis Pasteur; Oncologie
Le Coudray, , France
Clinique Victor Hugo; Radiotherapie
Le Mans, , France
Polyclinique Du Bois; Oncologie
Lille, , France
Centre Oscar Lambret; Unite de Recherche Clinique
Lille, , France
Ch Bretagne Sud Site Scorff; Oncologie Medicale
Lorient, , France
Centre Leon Berard
Lyon, , France
Clinique De La Sauvegarde; Chimiotherapie
Lyon, , France
Hopital Prive Jean Mermoz
Lyon, , France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, , France
Hopital de Mercy ;ONCOLOGIE MEDICALE
Melz-sur-Seine, , France
Hopital Belle Isle; Oncologie Hematologie
Metz, , France
Clinique Clementville; Hopital De Jour
Montpellier, , France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, , France
Centre Catherine de Sienne; Chimiotherapie
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Institut de cancerologie du Gard
Nîmes, , France
HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
Orléans, , France
APHP - Hopital de la Pitie Salpetriere
Paris, , France
Groupe Hospitalier Diaconesses
Paris, , France
Institut Curie; Oncologie Medicale
Paris, , France
Hopital Saint Louis; Oncologie Medicale
Paris, , France
HOPITAL TENON; Cancerologie Medicale
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
CH d'Annecy
Pringy, , France
Chi De Cornouaille; Oncologie Hospitalisation
Quimper, , France
Institut Jean Godinot; Oncologie Medicale
Reims, , France
Institut du Cancer Coulancy Reims
Reims, , France
Centre Eugene Marquis; Bureau D Etudes Cliniques
Rennes, , France
Centre Henri Becquerel; Oncologie Medicale
Rouen, , France
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint-Grégoire, , France
Centre Rene Gauducheau
Saint-Herblain, , France
Polyclinique de la Cote Basque Sud; Oncologie
Saint-Jean-de-Luz, , France
CMCO De La Cote D Opale; Auberge De Jour
Saint-Martin-Boulogne, , France
Clinique Mutualiste L Estuaire
Saint-Nazaire, , France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, , France
CH de Saint Quentin
Saint-Quentin, , France
Hopital Prive Nord Parisien; Soins De Suite - Oncologie
Sarcelles, , France
Clinique Ste Anne
Strasbourg, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Hopital de Hautepierre
Strasbourg, , France
Hôpital Rangueil - CHU de Toulouse
Toulouse, , France
Clinique Pasteur; Oncologie Medicale
Toulouse, , France
Countries
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References
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Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.
Other Identifiers
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2012-003442-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML28589
Identifier Type: -
Identifier Source: org_study_id
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