Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT01120561
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-02-15
First Post:
2010-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
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': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}], 'ancestors': [{'id': 'D008453', 'term': 'Maytansine'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'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': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2010-05'}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2010-05-07', 'studyFirstSubmitQcDate': '2010-05-07', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['TDM-1 EAP', 'T-DM1 EAP', 'TDM1 EAP', 'Trastuzumab-MCC-DM1 EAP', 'Trastuzumab emtansine', 'EAP', 'T-PAS'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented breast cancer\n* Locally advanced or metastatic breast cancer\n* HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment\n* Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer\n* Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting\n* Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen\n* Progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy\n* Adequate hematologic and end organ function\n* Agreement to use an effective form of birth control throughout the study\n* Life expectancy ≥ 90 days as assessed by the investigator\n\nExclusion Criteria:\n\n* Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy\n* Prior T-DM1 therapy\n* History of exposure to cumulative doses of select anthracyclines\n* History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued\n* Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment\n* Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment\n* History of clinically significant cardiac dysfunction\n* Current known active infection with HIV, hepatitis B virus, or hepatitis C virus\n* Current severe, uncontrolled systemic disease\n* Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment\n* Pregnancy or lactation\n\nNOTE: The site selection process has been completed. Patients can enroll at participating sites.'}, 'identificationModule': {'nctId': 'NCT01120561', 'briefTitle': 'A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Expanded Access, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'TDM4884g'}}, 'armsInterventionsModule': {'interventions': [{'name': 'trastuzumab-MCC-DM1', 'type': 'DRUG', 'description': 'Intravenous repeating dose'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92346', 'city': 'Highland', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 34.12834, 'lon': -117.20865}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63011', 'city': 'Clarkson Valley', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 38.61839, 'lon': -90.58929}}, {'zip': '87401', 'city': 'Farmington', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 36.72806, 'lon': -108.21869}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}