Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT03742102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-24', 'mcpReleaseN': 61, 'releaseDate': '2025-11-13'}], 'estimatedResultsFirstSubmitDate': '2025-11-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'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': 'C000613593', 'term': 'durvalumab'}, {'id': 'C575618', 'term': 'capivasertib'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C000614160', 'term': 'trastuzumab deruxtecan'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1:\n\nAt least 20 patients in the durvalumab-paclitaxel arm and at least 30 patients in each of the other novel treatment combination arms will be enrolled, for a total of approximately 140 patients (durvalumab + paclitaxel arm and 4 novel treatment combination arms). Additional patients may be enrolled in order to have 20 or 30 evaluable (i.e. dosed) patients per durvalumab - paclitaxel arm or novel treatment combination arm, respectively.\n\nPart 2:\n\nApproximately 27 patients will be assigned to each treatment arm, for an anticipated total of 57 response-evaluable patients per arm (ie, 30 patients in Part 1 and 27 patients in Part 2 per treatment arm, with the exception of Arm 1, which will enroll 20 patients in Part 1 and will not be expanded to Part 2). Patient expansion from 30 patients in Part 1 to an additional 27 patients from Part 2 will be determined based on a futility analysis utilizing a Simon 2 Stage design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Part1: From informed consent until the safety follow-up visit 3 months after the last dose of study drug. Part 2: From informed consent until the safety follow-up visit 3 months after the last dose of study drug.', 'description': 'Part 1: Assessment of safety and tolerability of each treatment arm\n\nPart 2:\n\nEndpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).'}, {'measure': 'Laboratory findings', 'timeFrame': 'Part 1: From informed consent until the safety follow-up visit 3 months after the last dose of study drug. Part 2:From informed consent until the safety follow-up visit 3 months after the last dose of study drug.', 'description': 'Assessment of safety and tolerability of each treatment arm'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Approx. 30 months', 'description': 'Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed response of CR (complete response) or PR (partial response) Applicable for Part 1 and Part 2.'}, {'measure': 'Progression-free survival (PFS).', 'timeFrame': 'On-study tumor assessments occur every 8 weeks (Arms 1-5),every 6 weeks (Arms 6-8) until week 48 and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months', 'description': 'Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of first dose until the date of objective radiological disease progression or death (by any cause in the absence of progression)\n\nApplicable for Part 1 and Part 2'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'On-study tumor assessments occur every 8 weeks (Arms 1-5), every 6 weeks (Arms 6-8) until week 48 and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months', 'description': 'Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression Applicable for Part 1 and Part 2'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Approx. 30 months', 'description': 'OS: Time from date of first dose until the date of death by any cause\n\nApplicable for Part 1 and Part 2'}, {'measure': 'Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies', 'timeFrame': 'From cycle 1 day 1 until cycle 7 day 1 (Arms 1-5), from cycle 1 day 1 until cycle 8 day 1 (Arms 6-8) (each cycle is 28 days) and every 12 weeks thereafter until study completion approx. 30 months', 'description': 'Assessment of pharmacokinetics (PK) Applicable for Part 1 (Arms 1-8) and for Part 2 (Arm 7)'}, {'measure': 'Presence of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies', 'timeFrame': 'From cycle 1 day 1 until cycle 7 day 1 (Arms 1-5), from cycle 1 day 1 until cycle 8 day 1 (Arms 6-8) (each cycle is 28 days) and every 12 weeks thereafter until study completion approx. 30 months', 'description': 'Investigation of the immunogenicity of durvalumab and novel oncology therapies in all applicable treatment arms Applicable for Part 1 (Arms 1-8) and for Part 2 (Arm 7)'}, {'measure': 'Progression-free survival (PFS 6)', 'timeFrame': 'On-study tumor assessments occur every 8 weeks until week 48 (Arms 1-5), every 6 weeks until week 48 (Arms 6-8) and then every 12 weeks thereafter until radiological progression, death, withdrawal of consent or study completion up to approx. 30 months', 'description': 'PFS at 6 months following date of first dose Applicable for Part 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'TNBC', 'Triple Negative', 'Triple Negative Breast Cancer', 'Triple-Negative Breast Cancer', 'Triple-Negative Breast Neoplasm', 'ER-Negative PR-Negative HER2-Negative Breast Cancer', 'ER-Negative PR-Negative HER2-Negative Breast Neoplasms', 'PD-L1 high TNBC'], 'conditions': ['Triple Negative Breast Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.breastcancerstudylocator.com/trial/listing/188918', 'label': 'Breast Cancer Study Locator details (for US)'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer', 'detailedDescription': 'This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion.\n\nPart 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Female\n2. At least 18 years of age at the time of screening\n3. Patient must have locally confirmed advanced/unresectable or metastatic TNBC.\n4. No prior treatment for metastatic (Stage IV) TNBC\n5. Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured\n6. WHO/ECOG status at 0 or 1 at enrollment\n\nPatients enrolled to Arm 6 (durvalumab and DS-8201a) Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)\n\nPatients enrolled in Arm 8 (durvalumab + Dato-DXd) Must have PD-L1 positive tumor as determined by an IHC based assay\n\nExclusion criteria\n\n1. History of allogeneic organ transplantation\n2. Active or prior documented autoimmune or inflammatory disorders\n3. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)\n4. Untreated CNS metastases\n5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients\n6. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment\n7. Female patients who are pregnant, breastfeeding\n8. Cardiac Ejection Fraction less than 50%\n\nPatients enrolled in Arm 2 only:\n\n1. Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)\n2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment.\n3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval\n4. Prior treatment with PI3K inhibitors, AKT inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.\n\nPatients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months\n\nPatients enrolled in Arm 7 and 8 only: Clinically significant corneal disease in the opinion of the Investigator.\n\nPatients enrolled in Arm 6, 7 and 8 only:\n\n1. History of or active interstitial lung disease/pneumonitis\n2. Use of chloroquine or hydroxychloroquine in \\<14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (DS-1062a; Arm 7 and 8) treatment\n3. Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy."}, 'identificationModule': {'nctId': 'NCT03742102', 'acronym': 'BEGONIA', 'briefTitle': 'A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'D933LC00001'}, 'secondaryIdInfos': [{'id': '2018-000764-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'durvalumab + paclitaxel', 'interventionNames': ['Drug: Durvalumab', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'durvalumab + paclitaxel + capivasertib', 'interventionNames': ['Drug: Durvalumab', 'Drug: Capivasertib', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'durvalumab + paclitaxel + oleclumab', 'interventionNames': ['Drug: Durvalumab', 'Drug: Oleclumab', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': 'durvalumab + trastuzumab deruxtecan', 'interventionNames': ['Drug: Durvalumab', 'Drug: Trastuzumab deruxtecan']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7', 'description': 'durvalumab + datopotamab deruxtecan', 'interventionNames': ['Drug: Durvalumab', 'Drug: Datopotamab deruxtecan']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8', 'description': 'durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)', 'interventionNames': ['Drug: Durvalumab', 'Drug: Datopotamab deruxtecan']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 5', 'Arm 6', 'Arm 7', 'Arm 8']}, {'name': 'Capivasertib', 'type': 'DRUG', 'otherNames': ['AZD5363'], 'description': 'Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off', 'armGroupLabels': ['Arm 2']}, {'name': 'Oleclumab', 'type': 'DRUG', 'otherNames': ['MEDI9447'], 'description': 'Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1', 'armGroupLabels': ['Arm 5']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 5']}, {'name': 'Trastuzumab deruxtecan', 'type': 'DRUG', 'otherNames': ['DS-8201a'], 'description': 'Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w', 'armGroupLabels': ['Arm 6']}, {'name': 'Datopotamab deruxtecan', 'type': 'DRUG', 'otherNames': ['Dato-DXd; DS-1062a'], 'description': 'Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w', 'armGroupLabels': ['Arm 7', 'Arm 8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 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{'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-090', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '45-060', 'city': 'Opole', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '35-021', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-141', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '80756', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '70403', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Research Site', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Peter Schmid, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts Cancer Institute'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}