Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT00201851
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive 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': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D010052', 'term': 'Ovariectomy'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002369', 'term': 'Castration'}, {'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richardibcrf@gmail.com', 'phone': '608-698-7881', 'title': 'Richard R. Love', 'organization': 'International Breast Cancer Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over entire course of study', 'eventGroups': [{'id': 'EG000', 'title': 'A - Scheduled Surgery', 'description': 'Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'otherNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B - Immediate Surgery', 'description': 'Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'otherNumAtRisk': 255, 'otherNumAffected': 0, 'seriousNumAtRisk': 255, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'C- Immediate Surgery - Nonrandomized', 'description': 'Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'otherNumAtRisk': 230, 'otherNumAffected': 0, 'seriousNumAtRisk': 230, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocervical cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nosocomial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 244, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'A - Scheduled Surgery', 'description': 'Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'OG001', 'title': 'B - Immediate Surgery', 'description': 'Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'OG002', 'title': 'C- Immediate Surgery - Nonrandomized', 'description': 'Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'two- to three-year accrual and initial two or more years of follow-up period', 'description': '5-year disease-free survival', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A - Scheduled Surgery', 'description': 'Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'FG001', 'title': 'B - Immediate Surgery', 'description': 'Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'FG002', 'title': 'C- Immediate Surgery - Nonrandomized', 'description': 'Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '257'}, {'groupId': 'FG002', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '255'}, {'groupId': 'FG002', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ineligible post enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '729', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'A - Scheduled Surgery', 'description': 'Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'BG001', 'title': 'B - Immediate Surgery', 'description': 'Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'BG002', 'title': 'C- Immediate Surgery - Nonrandomized', 'description': 'Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization\n\nTamoxifen: 20 mg po daily x 5 years\n\nSurgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '4.4', 'groupId': 'BG002'}, {'value': '42.2', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '729', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estrogen receptor status', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}, {'value': '678', 'groupId': 'BG003'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Progesterone receptor status', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '671', 'groupId': 'BG003'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HER2/Neu status', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of positive axillary nodes', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}]}]}, {'title': '1-3', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}]}, {'title': '4+', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pathologic tumor size', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '4.5', 'spread': '2.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Progesterone level on day of surgery (ng/ml)', 'classes': [{'title': '<2', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '307', 'groupId': 'BG003'}]}]}, {'title': '2-4.99', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': '5+', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline measures were not available on all participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 740}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-13', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-13', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival', 'timeFrame': 'two- to three-year accrual and initial two or more years of follow-up period', 'description': '5-year disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asian', 'Premenopausal', 'Women', 'Oophorectomy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31443726', 'type': 'DERIVED', 'citation': 'Hade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9.'}]}, 'descriptionModule': {'briefSummary': 'This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open for accrual in Asia only\n* Female age 18-50,\n* premenopausal with regular cycles (\\>25-35 in length)\n* fine-needle aspiration diagnosis\n* Stage II-IIIA hormone receptor positive invasive breast cancer\n* No prior radiation or chemotherapy\n* Must be surgical candidate for bilateral oophorectomy'}, 'identificationModule': {'nctId': 'NCT00201851', 'briefTitle': 'Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'International Breast Cancer Research Foundation'}, 'officialTitle': 'Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer', 'orgStudyIdInfo': {'id': 'OSU-0483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate surgery', 'description': 'Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', 'interventionNames': ['Drug: Tamoxifen', 'Procedure: Surgery: Oophorectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Scheduled surgery', 'description': 'Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', 'interventionNames': ['Drug: Tamoxifen', 'Procedure: Surgery: Oophorectomy']}, {'type': 'OTHER', 'label': 'Immediate Surgery - nonrandomized', 'description': 'Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization', 'interventionNames': ['Drug: Tamoxifen', 'Procedure: Surgery: Oophorectomy']}], 'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG', 'otherNames': ['Nolvadex®'], 'description': '20 mg po daily x 5 years', 'armGroupLabels': ['Immediate Surgery - nonrandomized', 'Immediate surgery', 'Scheduled surgery']}, {'name': 'Surgery: Oophorectomy', 'type': 'PROCEDURE', 'otherNames': ['ovary removal surgery'], 'description': 'Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'armGroupLabels': ['Immediate Surgery - nonrandomized', 'Immediate surgery', 'Scheduled surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rabat', 'country': 'Morocco', 'facility': 'National Institute of Oncology', 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}, {'city': 'Cebu', 'country': 'Philippines', 'facility': 'Vicente Soto Memorial Medical Center', 'geoPoint': {'lat': 16.75187, 'lon': 121.5961}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'East Avenue Medical Center', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Rizal', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Santo Toma Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Da Nang', 'country': 'Vietnam', 'facility': 'Danang General', 'geoPoint': {'lat': 16.06778, 'lon': 108.22083}}, {'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Hospital K, National Cancer Institute', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Huế', 'country': 'Vietnam', 'facility': 'Hue Central', 'geoPoint': {'lat': 16.4619, 'lon': 107.59546}}], 'overallOfficials': [{'name': 'Richard R. Love, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Breast Cancer Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Breast Cancer Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}