Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT00634634
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2008-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'toppmede@cinj.rutgers.edu', 'phone': '732-235-5203', 'title': 'Dr. Deborah Toppmeyer', 'organization': 'Cancer Institute of New Jersey'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 4.6 years', 'eventGroups': [{'id': 'EG000', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily', 'description': 'Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study\n\nDose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily', 'description': 'Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'deathsNumAffected': 24, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dermatology/Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 67, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 23, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 64, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 39, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 72, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constitutional Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 26, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatobiliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)', 'description': 'The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.'}], 'classes': [{'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'twenty eight days', 'description': 'The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.', 'unitOfMeasure': 'milligrams twice daily', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome is the maximum tolerated dose, which is the highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose was only analyzed. Then phase 2 added 39 participates.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG001', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily', 'description': 'Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG002', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG003', 'title': 'Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily', 'description': 'Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer.\n\nClinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Progressive-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG001', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily', 'description': 'Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG002', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG003', 'title': 'Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily', 'description': 'Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '15'}, {'value': '34.5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '66'}, {'value': '11', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 4.6 years', 'description': 'PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Assessed as Mean Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG001', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily', 'description': 'Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG002', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'OG003', 'title': 'Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily', 'description': 'Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '44'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '25'}, {'value': '49.6', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '56'}, {'value': '24.8', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '49'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 4.6 years', 'description': 'From the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'FG001', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily', 'description': 'Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study\n\nDose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'FG002', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'FG003', 'title': 'Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily', 'description': 'Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '13 participants in Phase I + 39 participants enrolled in Phase II = 52 participants that appear to be enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'BG001', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily', 'description': 'Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study\n\nDose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'BG002', 'title': 'Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day', 'description': 'Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.\n\nDose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28'}, {'id': 'BG003', 'title': 'Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily', 'description': 'Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-08', 'size': 26919982, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-25T14:57', 'hasProtocol': True}, {'date': '2013-02-13', 'size': 9523126, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-13T18:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2008-03-05', 'resultsFirstSubmitDate': '2022-10-08', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-03', 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)', 'timeFrame': 'twenty eight days', 'description': 'The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.'}], 'secondaryOutcomes': [{'measure': 'Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib', 'timeFrame': '6 months', 'description': 'Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer.\n\nClinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD)'}, {'measure': 'Median Progressive-Free Survival (PFS)', 'timeFrame': 'Approximately 4.6 years', 'description': 'PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression.'}, {'measure': 'Overall Survival (OS) Assessed as Mean Months', 'timeFrame': 'Approximately 4.6 years', 'description': 'From the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'Postmenopausal Women with Hormone Receptor-Positive Locally Advanced Breast Cancer'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed invasive breast cancer\n2. Stage IIIB, IIIC with T4 lesion or Stage IV disease\n3. Breast cancer must be ER-positive and/or PR-positive\n4. Age ³ 18 years of age\n5. ECOG performance status 0, 1 or 2\n6. Able to swallow and oral medication\n7. Adequate end organ function\n8. Written informed consent\n\nExclusion Criteria:\n\n1. Prior hormonal therapy for metastatic disease\n2. Prior chemotherapy for metastatic disease\n3. Prior treatment with sorafenib\n4. Brain metastases or leptomeningeal disease\n5. Evidence or history of bleeding\n6. Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months'}, 'identificationModule': {'nctId': 'NCT00634634', 'briefTitle': 'Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '040706'}, 'secondaryIdInfos': [{'id': 'NJ 1107', 'type': 'OTHER', 'domain': 'CINJOG'}, {'id': '0220070284', 'type': 'OTHER', 'domain': 'IRB #'}, {'id': 'NCI-2012-00525', 'type': 'OTHER', 'domain': 'NCI #'}, {'id': '0220070284', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}, {'id': 'Pro2018001861', 'type': 'OTHER', 'domain': 'Rutgers IRB#'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorafenib and Letrozole', 'interventionNames': ['Drug: Sorafenib', 'Drug: Letrozole']}], 'interventions': [{'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['Nexavar'], 'description': 'sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.', 'armGroupLabels': ['Sorafenib and Letrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28', 'armGroupLabels': ['Sorafenib and Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08690', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital/University Medical Center', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}], 'overallOfficials': [{'name': 'Antoinette Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rutgers Cancer Institute of New Jersey', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Chief Medical Officer', 'investigatorFullName': 'Deborah Toppmeyer, MD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}