Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00776659
Status:
TERMINATED
Last Update Posted:
2013-11-19
First Post:
2008-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
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': 'C056516', 'term': 'exemestane'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated due to slow enrollment and observational nature of the study. Low number of participants enrolled was not sufficient to conduct the planned analysis. Study was not terminated due to safety concerns.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.', 'otherNumAtRisk': 39, 'otherNumAffected': 10, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'classes': [{'title': 'Locoregional/Distant Recurrence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Missing/No response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)', 'description': 'Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'classes': [{'title': 'Second primary or contralateral breast cancer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Missing/No response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until death (up to Year 3.5)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of aromasin therapy.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Aromasin Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until discontinuation (up to Year 3.5)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of aromasin therapy.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'classes': [{'title': 'Gynecological AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Venous thromboembolic events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskeletal AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Menopausal symptoms', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of aromasin therapy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'timeFrame': 'Baseline, Month 6, 12, 18, 24, 30, 36, 42', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'timeFrame': 'Baseline, Month 6, 12, 18, 24, 30, 36, 42', 'reportingStatus': 'POSTED', 'populationDescription': 'Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exemestane', 'description': 'Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2008-10-20', 'resultsFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-12', 'studyFirstPostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer', 'timeFrame': 'Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)', 'description': 'Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.'}, {'measure': 'Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer', 'timeFrame': 'Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Baseline until death (up to Year 3.5)'}, {'measure': 'Number of Participants Who Discontinued Aromasin Therapy', 'timeFrame': 'Baseline until discontinuation (up to Year 3.5)'}, {'measure': 'Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment', 'description': 'An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.'}, {'measure': 'Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42', 'timeFrame': 'Baseline, Month 6, 12, 18, 24, 30, 36, 42'}, {'measure': 'Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42', 'timeFrame': 'Baseline, Month 6, 12, 18, 24, 30, 36, 42'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin', 'Antineoplastic Hormonal Drugs', 'Aromasin'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991088&StudyName=An%20Observational%20Study%20Of%20Indian%20Breast%20Cancer%20Patients%20Receiving%0AAdjuvant%20Therapy%20With%20Aromasin%0A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.\n\n* Efficacy of the treatment with Aromasin®\n* Safety of the treatment with Aromasin®', 'detailedDescription': 'NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.\n\nExclusion Criteria:\n\n* Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.\n* Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.'}, 'identificationModule': {'nctId': 'NCT00776659', 'briefTitle': 'An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin', 'orgStudyIdInfo': {'id': 'A5991088'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'interventionNames': ['Other: Aromasin']}], 'interventions': [{'name': 'Aromasin', 'type': 'OTHER', 'otherNames': ['exemestane'], 'description': 'Non-Interventional study design.', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560 029', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '141 004', 'city': 'Ludhiana', 'state': 'Punjab', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '141 009', 'city': 'Ludhiana', 'state': 'Punjab', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '226 001', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}