Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02314156
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C461063', 'term': 'telapristone acetate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's-khan2@northwestern.edu', 'phone': '312-503-4236', 'title': 'Seema A. Khan, MD', 'organization': 'Northwestern University'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs collected from the time informed consent was signed and baseline procedures were completed through up to 5 weeks post-intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 25, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 21, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders and administrative site condition - other specify', 'notes': 'application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Levels of Telapristone Acetate in Breast Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'categories': [{'measurements': [{'value': '2.82', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '5.47'}, {'value': '103', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '336'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of mastectomy, up to 5 weeks from baseline', 'description': 'Post-therapy mean levels of telapristone acetate in breast tissue.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with post-therapy breast tissue samples'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Telapristone Acetate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '1.41'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '138'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of mastectomy, up to 5 weeks from baseline', 'description': 'Post-therapy plasma concentrations of telapristone acetate.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with plasma samples post-therapy.'}, {'type': 'SECONDARY', 'title': 'Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'title': 'Central Subalveolar', 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '3.61'}, {'value': '63.7', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '205'}]}]}, {'title': 'Central Deepest', 'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '2.12', 'upperLimit': '10.8'}, {'value': '133', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '248'}]}]}, {'title': 'Lateral Surface', 'categories': [{'measurements': [{'value': '6.76', 'groupId': 'OG000', 'lowerLimit': '2.55', 'upperLimit': '15.5'}, {'value': '214', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '354'}]}]}, {'title': 'Lateral Center', 'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '5.2'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '292'}]}]}, {'title': 'Medial Center', 'categories': [{'measurements': [{'value': '2.79', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '4.27'}, {'value': '121', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '389'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of mastectomy, up to 5 weeks from baseline', 'description': 'Post-therapy concentrations of telapristone acetate in 5 locations within breast tissue.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with post-therapy breast tissue samples.'}, {'type': 'SECONDARY', 'title': 'Changes in Cell Proliferation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '0.57'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Changes in cell proliferation (Ki67 labeling index) measured in percentage of positive cells from baseline to mastectomy by tumor status in ER positive tumors.', 'unitOfMeasure': '% positive', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with ER positive tumors.'}, {'type': 'SECONDARY', 'title': 'Changes in Serum Sex Hormone Concentrations: Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '75.1', 'upperLimit': '135'}, {'value': '-23.7', 'groupId': 'OG001', 'lowerLimit': '-97.5', 'upperLimit': '-1.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to mastectomy, up to 5 weeks post-intervention', 'description': 'Change in estradiol in premenopausal women from baseline to post-intervention compared between treatment groups', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Premenopausal women'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'title': 'Cognitive', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Body Pain', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Vasomotor', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Sexual problems', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Bladder', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Body Image', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Vaginal', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'participants'}, {'type': 'SECONDARY', 'title': 'Changes in Serum Sex Hormone Concentrations: Progesterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '1.51'}, {'value': '-2.36', 'groupId': 'OG001', 'lowerLimit': '-10.1', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Change in progesterone in premenopausal women from baseline to post-intervention compared between treatment groups', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Premenopausal women'}, {'type': 'SECONDARY', 'title': 'Changes in Serum Sex Hormone Concentrations: FSH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'OG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'classes': [{'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '4.28'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '-2.84', 'upperLimit': '2.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Change in FSH in premenopausal women from baseline to post-intervention compared between treatment groups', 'unitOfMeasure': 'mIU', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Premenopausal women'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'FG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Transdermal Telapristone Acetate)', 'description': 'Participants receive telapristone acetate transdermally and placebo PO QD for 4 weeks.\n\nTelapristone Acetate: Given transdermally applied to both breast skin\n\nPlacebo: Given PO'}, {'id': 'BG001', 'title': 'Arm II (Oral Telapristone Acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nTelapristone Acetate: Given PO\n\nPlacebo: Given transdermally applied to both breast skin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '9.27', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '13.41', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '11.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-27', 'size': 1959271, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-09-21T14:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2014-12-09', 'resultsFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-26', 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Levels of Telapristone Acetate in Breast Tissue', 'timeFrame': 'At the time of mastectomy, up to 5 weeks from baseline', 'description': 'Post-therapy mean levels of telapristone acetate in breast tissue.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentrations of Telapristone Acetate', 'timeFrame': 'At the time of mastectomy, up to 5 weeks from baseline', 'description': 'Post-therapy plasma concentrations of telapristone acetate.'}, {'measure': 'Within-breast Variation of Breast Tissue Concentration of Telapristone Acetate', 'timeFrame': 'At the time of mastectomy, up to 5 weeks from baseline', 'description': 'Post-therapy concentrations of telapristone acetate in 5 locations within breast tissue.'}, {'measure': 'Changes in Cell Proliferation', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Changes in cell proliferation (Ki67 labeling index) measured in percentage of positive cells from baseline to mastectomy by tumor status in ER positive tumors.'}, {'measure': 'Changes in Serum Sex Hormone Concentrations: Estradiol', 'timeFrame': 'Baseline to mastectomy, up to 5 weeks post-intervention', 'description': 'Change in estradiol in premenopausal women from baseline to post-intervention compared between treatment groups'}, {'measure': 'Change in Symptoms as Captured in the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) Questionnaire', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Mean change in symptoms as captured using the Breast Cancer Prevention Trial (BCPT) Eight Symptom Scale (BESS) questionnaire. A patient reported outcome, scores range from 0 (Not at All) to 4 (Extremely) when asked about experiencing symptoms. A positive change in scores indicates an increase in symptoms experienced and a negative change in scores indicates a decrease in symptoms experienced'}, {'measure': 'Changes in Serum Sex Hormone Concentrations: Progesterone', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Change in progesterone in premenopausal women from baseline to post-intervention compared between treatment groups'}, {'measure': 'Changes in Serum Sex Hormone Concentrations: FSH', 'timeFrame': 'Baseline to mastectomy (up to 5 weeks)', 'description': 'Change in FSH in premenopausal women from baseline to post-intervention compared between treatment groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['BRCA1 Mutation Carrier', 'BRCA2 Mutation Carrier', 'Ductal Breast Carcinoma In Situ', 'Lobular Breast Carcinoma In Situ', 'Stage 0 Breast Cancer', 'Stage IA Breast Cancer', 'Stage IB Breast Cancer', 'Stage IIA Breast Cancer', 'Stage IIB Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To demonstrate that mean levels of telapristone (telapristone acetate) in breast tissue following gel application will result in levels that are not more than 50% lower than those following oral administration.\n\nSECONDARY OBJECTIVES:\n\nI. To assess whether plasma concentrations of telapristone are significantly lower with transdermal than oral therapy.\n\nII. To compare within-breast variation of breast tissue concentration in transdermal and oral groups.\n\nIII. To measure changes in cell proliferation (marker of proliferation (Ki-67 labeling index).\n\nIV. Explore changes in gene expression in breast tissue related to telapristone therapy.\n\nV. Assess change in serum progesterone associated with telapristone therapy. VI. Assess the safety and tolerability of oral and transdermal administration. VII. Assess symptom measurements using BESS Questionnaire\n\nOUTLINE: Participants are randomized to 1 of 2 treatment arms.\n\nARM I (TRANSDERMAL TELAPRISTONE ACETATE): Patients receive telapristone acetate transdermally and placebo orally (PO) once daily (QD) for 4 weeks.\n\nARM II (ORAL TELAPRISTONE ACETATE): Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.\n\nAfter completion of study treatment, patients are followed up at day 60.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-II (including ductal carcinoma in situ), or prophylaxis (breast cancer, early onset \\[BRCA\\] mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 1 (Karnofsky \\>= 70%)\n* Total bilirubin \\< 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \\< 2.5 x ULN\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) \\< 2.5 x ULN\n* Creatinine \\< 2 x ULN\n* Alkaline phosphatase \\< 2.5 x ULN\n* Blood urea nitrogen \\< 2 x ULN\n* Willing to use non-hormonal contraception (adequate barrier-type contraception or intrauterine device \\[IUD\\]) from the time the pregnancy test is performed for the duration of study participation, and 30 days after study drug cessation (for women of childbearing potential only)\n* Ability to understand and the willingness to sign a written informed consent document\n* Willing and able to schedule mastectomy 4 weeks (+/- 7days) following start of study agent\n* Willing to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing\n* Negative urine pregnancy test result, for participants of child bearing potential, within 5 days prior to first dose of study medication; female of child-bearing potential is any woman (regardless of sexual orientation, whether she has undergone a tubal ligation, or remains celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; OR has had a menstrual period at any time in the preceding 12 consecutive months)\n* Willing to use alcohol in moderation while taking study agent\n\nExclusion Criteria:\n\n* The presence of skin invasion by the breast cancer, or inflammatory changes with skin edema AND erythema. Note: Paget\'s disease is permitted.\n* Women receiving a "nipple delay" procedure prior to mastectomy.\n* Women with skin diseases (psoriasis, eczema) on breast.\n* A history of thromboembolic disorder or cerebral vascular disease\n* Use of oral contraceptives or other hormonal treatments within eight weeks prior to the randomization or during the period of the study; women should not have used Depo-Provera in the preceding 6 months; use of hormone coated IUD like Mirena is allowed\n* Participants may not have received any other investigational agents in the previous 3 months\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to telapristone (i.e. other progesterone antagonists)\n* Taken tamoxifen or other selective estrogen/progesterone receptor modulators (SERMs/SPRMs) within two years prior to entering study or been required to discontinue SERM therapy due to thromboembolic or uterine toxicity\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* History of prior breast cancer-specific therapy within the previous 2 years; previous unilateral radiation in women scheduled for mastectomy of the contralateral side is allowed\n* Pregnant or breastfeeding\n* Currently taking spironolactone\n* Recent history (within 6 months) of alcoholism or drug abuse\n* Known active infection with human immunodeficiency virus (HIV), hepatitis A, B, or C'}, 'identificationModule': {'nctId': 'NCT02314156', 'briefTitle': 'Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy', 'orgStudyIdInfo': {'id': 'NCI 2013-01-03'}, 'secondaryIdInfos': [{'id': 'NCI-2014-02412', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'N01-CN-2012-00035'}, {'id': 'NCI 2013-01-03', 'type': 'OTHER', 'domain': 'Northwestern University'}, {'id': 'NWU2013-01-03', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'HHSN26100003', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (transdermal telapristone acetate)', 'description': 'Patients receive telapristone acetate transdermally and placebo PO QD for 4 weeks.', 'interventionNames': ['Drug: Telapristone Acetate', 'Other: Placebo', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (oral telapristone acetate)', 'description': 'Patients receive placebo transdermally and telapristone acetate PO QD for 4 weeks.', 'interventionNames': ['Drug: Telapristone Acetate', 'Other: Placebo', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Telapristone Acetate', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Proellex', 'Progenta'], 'description': 'Given transdermally', 'armGroupLabels': ['Arm I (transdermal telapristone acetate)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (transdermal telapristone acetate)']}, {'name': 'Telapristone Acetate', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Proellex', 'Progenta'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (oral telapristone acetate)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given transdermally', 'armGroupLabels': ['Arm II (oral telapristone acetate)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (transdermal telapristone acetate)', 'Arm II (oral telapristone acetate)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (transdermal telapristone acetate)', 'Arm II (oral telapristone acetate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Seema Khan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}