Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00004935
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2000-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, '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'}, {'id': 'D004358', 'term': 'Drug Therapy'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'whyStopped': 'Trial is Life long follow-up: to reduce ressources and costs - trial terminated prematurely.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2000-03-07', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression on combined HerChemo (TTPHerChemo)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '8 weeks'}, {'measure': 'Time to first progression', 'timeFrame': '8 weeks'}, {'measure': 'Time to treatment failure', 'timeFrame': '8 weeks'}, {'measure': 'Overall survival', 'timeFrame': '8 weeks'}, {'measure': 'Adverse events', 'timeFrame': '8 weeks'}, {'measure': 'Predictive value of serum HER2/neu ECD levels on clinical outcome', 'timeFrame': '8 weeks'}, {'measure': 'Conversion rate of estrogen receptor status', 'timeFrame': '8 weeks'}, {'measure': 'Association of immunoprofiles of erbB-1, erbB-2, erbB-3 and erbB-4 with clinical outcome', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '32046665', 'type': 'DERIVED', 'citation': 'Eppenberger-Castori S, Klingbiel D, Ruhstaller T, Dietrich D, Rufle DA, Rothgiesser K, Pagani O, Thurlimann B. Plasma HER2ECD a promising test for patient prognosis and prediction of response in HER2 positive breast cancer: results of a randomized study - SAKK 22/99. BMC Cancer. 2020 Feb 11;20(1):114. doi: 10.1186/s12885-020-6594-0.'}, {'pmid': '31500588', 'type': 'DERIVED', 'citation': 'Schmid S, Klingbiel D, Aebi S, Goldhirsch A, Mamot C, Munzone E, Nole F, Oehlschlegel C, Pagani O, Pestalozzi B, Rochlitz C, Thurlimann B, von Moos R, Weder P, Zaman K, Ruhstaller T. Long-term responders to trastuzumab monotherapy in first-line HER-2+ advanced breast cancer: characteristics and survival data. BMC Cancer. 2019 Sep 10;19(1):902. doi: 10.1186/s12885-019-6105-3.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer.\n\nPURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.', 'detailedDescription': 'In advanced HER2+ breast cancer the impact of combining Trastuzumab (T) and chemotherapy (chemo) versus T alone followed by the addition of chemo at disease progression has not been properly studied.\n\nThe trial compared efficacy, toxicity and quality of life of sequential administration of T followed, at progression, by combination with chemo (T\\>TChemo) versus the upfront combination of T and chemo (TChemo) in patients with HER2+ advanced breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed HER2-overexpressing metastatic breast carcinoma\n* Clinically or radiologically measurable or evaluable disease\n\n * Bidimensionally or unidimensionally measurable lesions\n* No ascitic, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as only indicator lesion\n* No known clinical brain or meningeal involvement\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 70\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* ECOG 0-1 OR\n* SAKK 0-1\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Hemoglobin at least 10 g/dL\n* Platelet count at least 100,000/mm\\^3\n* Absolute neutrophil count at least 2,000/mm\\^3\n\nHepatic:\n\n* Bilirubin normal\n* SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN) (3 times ULN if proven liver metastases) OR\n* No SGOT and/or SGPT greater than 1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.25 times ULN\n\nCardiovascular:\n\n* LVEF normal\n* No history of atrial ventricular arrhythmia, congestive heart failure, or angina pectoris, even if medically controlled\n* No history of second or third-degree heart blocks\n* No uncontrolled hypertension\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No pre-existing motor or sensory neuropathy grade 2 or greater\n* No psychiatric disorder that would preclude informed consent\n* No other prior malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No definite contraindications for use of corticosteroids\n* No other concurrent serious illness or medical condition\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior adjuvant or neoadjuvant chemotherapy allowed\n* No more than 2 prior chemotherapy regimens for metastatic disease\n* No prior cumulative dose of doxorubicin greater than 240 mg/m\\^2\n* No prior cumulative dose of epirubicin greater than 360 mg/m\\^2\n* No prior taxanes\n\nEndocrine therapy:\n\n* Prior hormonal therapy as adjuvant treatment or for metastatic disease allowed\n* No concurrent corticosteroids unless started more than 6 months prior to study and at low doses (i.e., no greater than 20 mg methylprednisolone or equivalent)\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No other concurrent anticancer drugs\n* No other concurrent experimental drugs\n* No concurrent bisphosphonates unless initiated more than 3 months prior to study\n\n * Chronic use allowed provided bone metastases are not sole indicator lesions'}, 'identificationModule': {'nctId': 'NCT00004935', 'briefTitle': 'Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Cancer Institute'}, 'officialTitle': 'Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.', 'orgStudyIdInfo': {'id': 'SAKK 22/99'}, 'secondaryIdInfos': [{'id': 'SWS-SAKK-22/99', 'type': 'OTHER', 'domain': 'SAKK'}, {'id': 'EU-99028', 'type': 'OTHER', 'domain': 'SAKK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Herceptin™ (Her)', 'description': 'Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy', 'interventionNames': ['Drug: Herceptin™ (Her)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Herceptin™+Chemo', 'description': 'Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy', 'interventionNames': ['Drug: Herceptin™ (Her) + chemo']}], 'interventions': [{'name': 'Herceptin™ (Her)', 'type': 'DRUG', 'description': 'Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy', 'armGroupLabels': ['Herceptin™ (Her)']}, {'name': 'Herceptin™ (Her) + chemo', 'type': 'DRUG', 'description': 'Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy', 'armGroupLabels': ['Herceptin™+Chemo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': 'CH-5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': 'CH-5404', 'city': 'Baden', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitaetsspital-Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Kantonsspital Graubuenden', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': 'CH-1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopital Cantonal Universitaire de Geneve', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Ospedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': 'CH-4310', 'city': 'Rheinfelden', 'country': 'Switzerland', 'facility': 'Praxis Dr. Beretta', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital - St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '3600', 'city': 'Thun', 'country': 'Switzerland', 'facility': 'Regionalspital', 'geoPoint': {'lat': 46.75118, 'lon': 7.62166}}, {'zip': '8038', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Onkozentrum', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8063', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'City Hospital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitaetsSpital Zuerich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Pagani Olivia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Oncologico della Svizzera Italiana IOSI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}