Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-02-28 @ 6:34 PM
Study NCT ID:
NCT03096418
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Sponsor:
Organization:
Raw JSON
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Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria', 'unitOfMeasure': 'percent decrease in tumor size', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 12 participants were evaluable because of insufficient specimen.'}, {'type': 'SECONDARY', 'title': 'Tumor Level Difference of Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.43', 'groupId': 'OG000'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Participant 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient tumor tissue collected by biopsy', 'groupId': 'OG000'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient tumor tissue collected by biopsy', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 day', 'description': 'Identify patient-specific differences in tumor levels of paclitaxel at 20 hours after first dose.\n\nThis is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.', 'unitOfMeasure': 'micromolar', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant 10 withdrew consent.'}, {'type': 'SECONDARY', 'title': 'Non-Tumor Level Difference of Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.040', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.027', 'groupId': 'OG000'}]}]}, {'title': 'Participant 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.031', 'groupId': 'OG000'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.020', 'groupId': 'OG000'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.013', 'groupId': 'OG000'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.020', 'groupId': 'OG000'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.038', 'groupId': 'OG000'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.040', 'groupId': 'OG000'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.094', 'groupId': 'OG000'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.048', 'groupId': 'OG000'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 day', 'description': 'Identify patient-specific differences in non-tumor (plasma) levels of paclitaxel at 20 hours after first dose.\n\nThis is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.', 'unitOfMeasure': 'micromolar', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant 10 withdrew consent'}, {'type': 'SECONDARY', 'title': 'Paclitaxel Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'First dose plasma paclitaxel', 'categories': [{'measurements': [{'value': '0.041', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.094'}]}]}, {'title': 'Third dose plasma paclitaxel', 'categories': [{'measurements': [{'value': '0.029', 'groupId': 'OG000', 'lowerLimit': '0.013', 'upperLimit': '0.062'}]}]}, {'title': 'First dose intratumoral paclitaxel', 'categories': [{'measurements': [{'value': '0.785', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '1.67'}]}]}, {'title': 'Third dose intratumoral paclitaxel', 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '2.40'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 79 days', 'description': 'Paclitaxel levels at the first dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing difference at two time points within the same patient with paired statistics.', 'unitOfMeasure': 'micromolars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antimitotic Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel - Baseline', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}, {'id': 'OG001', 'title': 'Weekly Paclitaxel - 20 Hours After First Dose', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}, {'id': 'OG002', 'title': 'Weekly Paclitaxel - 20 Hours After Third Dose', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}, {'id': 'OG003', 'title': 'Weekly Paclitaxel - 20 Hours After Twelfth Dose', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Participant 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Participant 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Participant 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 79 days', 'description': 'Compare pre-existing versus post-treatment antimitotic effects at 20 hours after the 1st dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose.\n\nThis is measured by tissue analysis of tumor samples with phospho-histone H3 and stains for spindle morphology to quantify mitotic index and mitotic characteristics at two time points using paired statistical analysis.', 'unitOfMeasure': 'number of mitotic cells', 'reportingStatus': 'POSTED', 'populationDescription': 'An increasing smaller subset of participants were biopsied after the first dose.'}, {'type': 'SECONDARY', 'title': 'Mitotic Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel - Pre-treatment', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}, {'id': 'OG001', 'title': 'Weekly Paclitaxel - 20 Hours Post-first Dose', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3.379722', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.192745', 'groupId': 'OG001'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.052765', 'groupId': 'OG000'}, {'value': '2.305837', 'groupId': 'OG001'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '3.201638', 'groupId': 'OG001'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '1.29731', 'groupId': 'OG001'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.466667', 'groupId': 'OG000'}, {'value': '1.872558', 'groupId': 'OG001'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.198311', 'groupId': 'OG000'}, {'value': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000'}, {'value': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000'}, {'value': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000'}, {'value': '5.56', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 20 hours post-first dose', 'description': 'The mitotic index is a measure of cells arresting in mitosis, previously thought to be the major mechanism of taxol action. It is defined as the percentage of cells undergoing mitosis in a given population of cells. An elevated mitotic index indicates more cells are at this phase of the cell cycle at the time of sampling.', 'unitOfMeasure': 'mitotic index', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Response reported here.'}, {'type': 'SECONDARY', 'title': 'Correlate Drug Levels With Aneuploidy of Tumor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'timeFrame': 'Up to 3 months', 'description': 'Correlate pathologic response and clinical response with biomarkers including aneuploidy', 'reportingStatus': 'POSTED', 'populationDescription': 'This biomarker was not measured'}, {'type': 'SECONDARY', 'title': 'Correlate Drug Levels With Chromosomal Instability of Tumor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'timeFrame': 'Up to 3 months', 'description': 'Correlate pathologic response and clinical response with biomarkers including CIN', 'reportingStatus': 'POSTED', 'populationDescription': 'This was not measured'}, {'type': 'SECONDARY', 'title': 'Ki67 of Tumor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'The Ki-67 protein is a cellular marker for proliferation. Ki-67 is an excellent marker to determine the growth fraction of a given cell population. The fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) is often correlated with the clinical course of cancer.', 'unitOfMeasure': 'Percentage of Ki67 + cells', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Response reported here.'}, {'type': 'SECONDARY', 'title': 'Change in CIN Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Weekly Paclitaxel Pre-treatment', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}, {'id': 'OG001', 'title': 'Weekly Paclitaxel - 20 Hours After First Dose', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'classes': [{'title': 'Participant 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.08', 'groupId': 'OG000'}, {'value': '51.38', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.44', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.44', 'groupId': 'OG000'}, {'value': '26.92', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.96039604', 'groupId': 'OG000'}, {'value': '29.12621359', 'groupId': 'OG001'}]}]}, {'title': 'Participant 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.98113208', 'groupId': 'OG000'}, {'value': '60.18518519', 'groupId': 'OG001'}]}]}, {'title': 'Participant 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.797468354', 'groupId': 'OG000'}, {'value': '64.0776699', 'groupId': 'OG001'}]}]}, {'title': 'Participant 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.33333333', 'groupId': 'OG000'}, {'value': '62.96296296', 'groupId': 'OG001'}]}]}, {'title': 'Participant 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.571428571', 'groupId': 'OG000'}, {'value': '61.9047619', 'groupId': 'OG001'}]}]}, {'title': 'Participant 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '27.27', 'groupId': 'OG001'}]}]}, {'title': 'Participant 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '56.6', 'groupId': 'OG001'}]}]}, {'title': 'Participant 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}]}]}, {'title': 'Participant 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.95', 'groupId': 'OG000'}, {'value': '58.82', 'groupId': 'OG001'}]}]}, {'title': 'Participant 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 20 hours post-first dose', 'description': 'There are many proposed ways to measure CIN. Here, we used # of multipolar spindles as a surrogate of CIN measures.', 'unitOfMeasure': '% of cells with multipolar spindles', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient tissue was collected to complete analysis on remaining participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Paclitaxel Concentration Determine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Analyzed After First Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Analyzed After Third Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Analyzed After Twelfth Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.\n\nPaclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-23', 'size': 482023, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-16T08:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2017-03-16', 'resultsFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-10-11', 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to Paclitaxel', 'timeFrame': 'Up to 3 months', 'description': 'To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria'}], 'secondaryOutcomes': [{'measure': 'Tumor Level Difference of Paclitaxel', 'timeFrame': 'Up to 1 day', 'description': 'Identify patient-specific differences in tumor levels of paclitaxel at 20 hours after first dose.\n\nThis is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.'}, {'measure': 'Non-Tumor Level Difference of Paclitaxel', 'timeFrame': 'Up to 1 day', 'description': 'Identify patient-specific differences in non-tumor (plasma) levels of paclitaxel at 20 hours after first dose.\n\nThis is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.'}, {'measure': 'Paclitaxel Levels', 'timeFrame': 'Up to 79 days', 'description': 'Paclitaxel levels at the first dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing difference at two time points within the same patient with paired statistics.'}, {'measure': 'Antimitotic Effects', 'timeFrame': 'Up to 79 days', 'description': 'Compare pre-existing versus post-treatment antimitotic effects at 20 hours after the 1st dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose.\n\nThis is measured by tissue analysis of tumor samples with phospho-histone H3 and stains for spindle morphology to quantify mitotic index and mitotic characteristics at two time points using paired statistical analysis.'}, {'measure': 'Mitotic Index', 'timeFrame': 'Baseline and 20 hours post-first dose', 'description': 'The mitotic index is a measure of cells arresting in mitosis, previously thought to be the major mechanism of taxol action. It is defined as the percentage of cells undergoing mitosis in a given population of cells. An elevated mitotic index indicates more cells are at this phase of the cell cycle at the time of sampling.'}, {'measure': 'Correlate Drug Levels With Aneuploidy of Tumor', 'timeFrame': 'Up to 3 months', 'description': 'Correlate pathologic response and clinical response with biomarkers including aneuploidy'}, {'measure': 'Correlate Drug Levels With Chromosomal Instability of Tumor', 'timeFrame': 'Up to 3 months', 'description': 'Correlate pathologic response and clinical response with biomarkers including CIN'}, {'measure': 'Ki67 of Tumor', 'timeFrame': 'Up to 3 months', 'description': 'The Ki-67 protein is a cellular marker for proliferation. Ki-67 is an excellent marker to determine the growth fraction of a given cell population. The fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) is often correlated with the clinical course of cancer.'}, {'measure': 'Change in CIN Levels', 'timeFrame': 'Baseline and 20 hours post-first dose', 'description': 'There are many proposed ways to measure CIN. Here, we used # of multipolar spindles as a surrogate of CIN measures.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasm Female']}, 'referencesModule': {'references': [{'pmid': '34516829', 'type': 'RESULT', 'citation': "Scribano CM, Wan J, Esbona K, Tucker JB, Lasek A, Zhou AS, Zasadil LM, Molini R, Fitzgerald J, Lager AM, Laffin JJ, Correia-Staudt K, Wisinski KB, Tevaarwerk AJ, O'Regan R, McGregor SM, Fowler AM, Chappell RJ, Bugni TS, Burkard ME, Weaver BA. Chromosomal instability sensitizes patient breast tumors to multipolar divisions induced by paclitaxel. Sci Transl Med. 2021 Sep 8;13(610):eabd4811. doi: 10.1126/scitranslmed.abd4811. Epub 2021 Sep 8."}], 'seeAlsoLinks': [{'url': 'http://www.uwhealth.org/uw-carbone-cancer-center/cancer/10252', 'label': 'UW Carbone Cancer Center Home Page'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.', 'detailedDescription': 'Primary Objectives\n\n* To test if cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers.\n\nSecondary Objectives\n\n* To identify patient-specific differences in tumor levels and distribution of paclitaxel at 20 hours after first dose and patient-specific differences in peripheral non-tumor tissue (skin or plasma) paclitaxel levels 20 ± 4 hours after first dose.\n* To determine if paclitaxel levels are higher at 20h after the 3rd dose than after the first dose, and if levels are higher at 20h after the 10th, 11th, or 12th dose than the 1st and 3rd dose.\n* Compare pre-existing versus post-treatment antimitotic effects at 20h after the 1st dose, 20h after the 3rd dose, and 20h after the 10th, 11th, or 12th dose.\n* Correlate drug levels and distribution with biomarkers including mitotic index, aneuploidy, chromosomal instability, and Ki67.\n* Correlate pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, CIN and Ki67.\n* To test if CIN increases in patient tumors in response to paclitaxel and to evaluate the feasibility of these measurements by genomic analysis.\n\nInitial Actual Primary and Study Completion Date registered as 8/16/2022 with 24 participants enrolled.\n\nPer a Protocol Amendment dated 5/7/24, this study will re-open to enroll up to 50 participants. NCI funding and data sharing information added.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with pathologically demonstrated breast cancer\n* Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel.\n* Patients must not have metastatic disease on staging work-up per institutional guidelines.\n* A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor or lymph node. A minimum of 8 slides must be available.\n* The primary tumor or lymph node must be readily biopsied by surgery or radiology teams.\n* The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians.\n* Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted.\n* Patients must have adequate organ and marrow function as determined by the treating oncologist.\n* Patient must be willing to undergo additional biopsy of breast tumor or lymph node.\n* Patient must have the ability and willingness to sign a written informed consent document.\n* Women of childbearing potential (per UWCCC policy definition) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil).\n* Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications.\n* Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial."}, 'identificationModule': {'nctId': 'NCT03096418', 'briefTitle': 'Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response', 'orgStudyIdInfo': {'id': 'UW16106'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00338', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}, {'id': '2016-1489', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A534260', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\MEDICINE\\HEM-ONC', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 6/12/2025', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R01CA284747-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA284747-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weekly Paclitaxel', 'description': 'Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.\n\nParticipants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.', 'interventionNames': ['Drug: Paclitaxel']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': 'Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.', 'armGroupLabels': ['Weekly Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cancer Connect', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}], 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Cancer Connect', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}], 'overallOfficials': [{'name': 'Malinda West, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}