Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT01810393
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-11', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score', 'timeFrame': 'Baseline up to 6 cycles (cycle length = 21 days)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'approximately 4 years'}, {'measure': 'Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score', 'timeFrame': 'Baseline up to 6 cycles (cycle length = 21 days)'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28648618', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': 'This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed HER2-positive metastatic breast cancer\n* On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years\n* Left ventricular ejection fraction (LVEF) of greater than or equal to (\\>/=) 50 percent (%)\n* Hormonal therapy will be allowed\n* Prior use of anti-HER2 therapy will be allowed\n\nExclusion Criteria:\n\n* History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years; participants with previous ductal carcinoma in situ of the breast are also eligible\n* Participants with severe dyspnea at rest or requiring supplementary oxygen therapy\n* Serious cardiac illness or medical conditions that would preclude the use of trastuzumab\n* Hepatitis B, hepatitis C or human immunodeficiency virus infection\n* Pregnant or lactating women\n* 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\n* 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\n* Central nervous system metastases, unless they have been treated and have been stable for at least 3 years\n* Inadequate organ function'}, 'identificationModule': {'nctId': 'NCT01810393', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, Randomized, Multicenter Phase III Study in Patients With HER2-Positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab', 'orgStudyIdInfo': {'id': 'ML28589'}, 'secondaryIdInfos': [{'id': '2012-003442-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trastuzumab IV Then Trastuzumab SC', 'description': '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.', 'interventionNames': ['Drug: Trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Trastuzumab SC Then Trastuzumab IV', 'description': '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.', 'interventionNames': ['Drug: Trastuzumab']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': '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.', 'armGroupLabels': ['Trastuzumab IV Then Trastuzumab SC', 'Trastuzumab SC Then Trastuzumab IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47000', 'city': 'Agen', 'country': 'France', 'facility': 'Clinique Du Docteur Calabet; Cromg', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'zip': '80090', 'city': 'Amiens', 'country': 'France', 'facility': 'Clinique De L Europe; Radiotherapie Chimiotherapie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': 'ICO Paul Papin; Oncologie Medicale.', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '62012', 'city': 'Arras', 'country': 'France', 'facility': 'HOP Prive Arras Les Bonnettes; Chimiotherapie', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '84082', 'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte-Catherine; Oncologie', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'Centre Hospitalier de La Cote Basque; Oncologie', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'HOPITAL JEAN MINJOZ; Oncologie', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Centre Hospitalier Fleyriat; Oncologie/Hematologie', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Hopital Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29220', 'city': 'Brest', 'country': 'France', 'facility': 'Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Francois Baclesse; Oncologie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin; Oncologie', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63050', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Pole Sante Republique;Oncologie Hematologie', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Chi De Creteil; Radiotherapie Oncologie', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '59187', 'city': 'Dechy', 'country': 'France', 'facility': 'Centre Leonard De Vinci;Chimiotherapie', 'geoPoint': {'lat': 50.35, 'lon': 3.11667}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges Francois Leclerc; Oncologie 3', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Les Oudairies', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '28630', 'city': 'Le Coudray', 'country': 'France', 'facility': 'Ch Louis Pasteur; Oncologie', 'geoPoint': {'lat': 48.42115, 'lon': 1.50057}}, {'zip': '72015', 'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique Victor Hugo; Radiotherapie', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59003', 'city': 'Lille', 'country': 'France', 'facility': 'Polyclinique Du Bois; Oncologie', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret; Unite de Recherche Clinique', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Ch Bretagne Sud Site Scorff; Oncologie Medicale', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69337', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique De La Sauvegarde; Chimiotherapie', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Prive Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes; Oncologie Medicale', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '57085', 'city': 'Melz-sur-Seine', 'country': 'France', 'facility': 'Hopital de Mercy ;ONCOLOGIE MEDICALE', 'geoPoint': {'lat': 48.49819, 'lon': 3.4177}}, {'zip': '57045', 'city': 'Metz', 'country': 'France', 'facility': 'Hopital Belle Isle; Oncologie Hematologie', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34070', 'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Clementville; Hopital De Jour', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'facility': 'Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44202', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Catherine de Sienne; Chimiotherapie', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Institut de cancerologie du Gard', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'facility': 'HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'APHP - Hopital de la Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Diaconesses', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75231', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie; Oncologie Medicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis; Oncologie Medicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'HOPITAL TENON; Cancerologie Medicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '74370', 'city': 'Pringy', 'country': 'France', 'facility': "CH d'Annecy", 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'Chi De Cornouaille; Oncologie Hospitalisation', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '51056', 'city': 'Reims', 'country': 'France', 'facility': 'Institut Jean Godinot; Oncologie Medicale', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Institut du Cancer Coulancy Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis; Bureau D Etudes Cliniques', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel; Oncologie Medicale', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '35768', 'city': 'Saint-Grégoire', 'country': 'France', 'facility': 'Chp Saint Gregoire; Cancerologie Radiotherapie', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre Rene Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '64501', 'city': 'Saint-Jean-de-Luz', 'country': 'France', 'facility': 'Polyclinique de la Cote Basque Sud; Oncologie', 'geoPoint': {'lat': 43.38871, 'lon': -1.66267}}, {'zip': '62280', 'city': 'Saint-Martin-Boulogne', 'country': 'France', 'facility': 'CMCO De La Cote D Opale; Auberge De Jour', 'geoPoint': {'lat': 50.72691, 'lon': 1.61864}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Clinique Mutualiste L Estuaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '42271', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie de Loire', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '2100', 'city': 'Saint-Quentin', 'country': 'France', 'facility': 'CH de Saint Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'zip': '95200', 'city': 'Sarcelles', 'country': 'France', 'facility': 'Hopital Prive Nord Parisien; Soins De Suite - Oncologie', 'geoPoint': {'lat': 48.99739, 'lon': 2.37821}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Clinique Ste Anne', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67065', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul Strauss; Oncologie Medicale', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Rangueil - CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur; Oncologie Medicale', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}