Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 12:05 AM
Study NCT ID:
NCT06757634
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2024-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'C000589651', 'term': 'ribociclib'}, {'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'C549060', 'term': 'gedatolisib'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 674}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2024-12-24', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From date of randomization to the date of death due to any cause, up to approximately 48 months', 'description': 'Progression Free Survival (PFS) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer\n\nPFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer', 'timeFrame': 'From date of randomization to the date of death due to any cause, up to approximately 48 months', 'description': 'OS is defined as the length of time from randomization until the date of death from any cause method, where PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)'}, {'measure': 'Overall Response Rate (ORR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer', 'timeFrame': 'Up to approximately 48 months', 'description': 'Percentage of subjects who achieved an objective response according to RECIST v1.1 criteria (complete response \\[CR\\] or partial response \\[PR\\]) as assessed by BICR)'}, {'measure': 'Overall Response Rate (ORR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer', 'timeFrame': 'Up to approximately 48 months', 'description': 'Percentage of subjects who achieved an objective response according to RECIST v1.1 (CR or PR) as assessed by BICR'}, {'measure': 'Duration of Response (DOR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer', 'timeFrame': 'Up to approximately 48 months', 'description': 'Time from the assessment of initial response (PR or better) to death or first documented radiologically confirmed disease progression as assessed by BICR, whichever occurs first'}, {'measure': 'Time to Response (TTR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer', 'timeFrame': 'Time from randomization to the first assessment of PR or better as assessed by BICR', 'description': 'Time to Response (TTR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer'}, {'measure': 'Clinical Benefit Rate (CBR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer', 'timeFrame': 'Up to approximately 48 months', 'description': 'Percentage of subjects with CR or PR; or with stable disease (SD) lasting \\>24 weeks as assessed by BICR'}, {'measure': 'Quality of Life (QOL) Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI)', 'timeFrame': 'From baseline to 30 Day Safety Follow-up', 'description': 'Questions in Patients with PIK3CA ND and PIK3CA MT Breast Cancer'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to approximately 48 months', 'description': 'Type, incidence, severity (as graded by the NCI CTCAE v5.0), seriousness, and relationship to study medications of Adverse Events and any laboratory abnormalities in Arm A compared with Arm B'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer, Advanced or Metastatic', 'Gedatolisib', 'HR Positive', 'ER Positive', 'HER2 Negative', 'PIK3CA MT', 'PI3K'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.', 'detailedDescription': "This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor (Investigator's choice of palbociclib or ribociclib) for the treatment of patients with advanced (inoperable) or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer whose disease has progressed during or within 12 months of adjuvant treatment with endocrine therapy (either an AI or tamoxifen), and who have not received prior systemic therapy for ABC. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Following completion of the safety run-in phase to determine the gedatolisib dose with ribociclib, subjects will be assigned to 1 of 2 cohorts based on their PIK3CA status and then randomized to either the investigational treatment arm (gedatolisib with fulvestrant and ribociclib or palbociclib) or standard-of-care control arm (fulvestrant and ribociclib or palbociclib)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer\n2. Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.\n3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.\n4. Progression of disease during or within 12 months of completing (neo)adjuvant ET.\n5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.\n6. Permitted prior therapies:\n\n 1. (neo)adjuvant fulvestrant or any selective ER degrader only if the treatment duration \\< 6 months\n 2. (neo)adjuvant chemotherapy\n 3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i\n7. Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with evaluable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n9. Life expectancy of at least \\>6 months.\n10. Adequate bone marrow, hepatic, renal and coagulation function.\n\nExclusion Criteria:\n\n1. Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.\n2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor\n3. Prior treatment with systemic anticancer therapy for ABC\n4. Subjects with type 1 diabetes\n5. Known and untreated, or active, brain or leptomeningeal metastases\n6. History of clinically significant cardiovascular abnormalities\n7. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis'}, 'identificationModule': {'nctId': 'NCT06757634', 'briefTitle': 'Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celcuity Inc'}, 'officialTitle': 'VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'CELC-G-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant', 'description': 'Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off', 'interventionNames': ['Drug: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant', 'Drug: Arm B: Palbociclib or Ribociclib + Fulvestrant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Palbociclib or Ribociclib + Fulvestrant', 'description': 'Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle', 'interventionNames': ['Drug: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant', 'Drug: Arm B: Palbociclib or Ribociclib + Fulvestrant']}], 'interventions': [{'name': 'Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant', 'type': 'DRUG', 'otherNames': ['PF-05212384, IBRANCE, KISQALI®, Faslodex'], 'description': 'Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off\n\nOther Names:\n\n• PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle.\n\nOther Names:\n\n• IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle\n\nOther Names:\n\n• KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks\n\nOther Names:\n\n• Faslodex', 'armGroupLabels': ['Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant', 'Arm B: Palbociclib or Ribociclib + Fulvestrant']}, {'name': 'Arm B: Palbociclib or Ribociclib + Fulvestrant', 'type': 'DRUG', 'otherNames': ['IBRANCE, KISQALI®, Faslodex'], 'description': 'Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle\n\nOther Names:\n\n• IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle\n\nOther Names:\n\n• KISQALI®\n\nDrug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4\n\nOther Names:\n\n• Faslodex', 'armGroupLabels': ['Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant', 'Arm B: Palbociclib or Ribociclib + Fulvestrant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '93003', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UCLA Hematology Oncology Ventura', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'The University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mercy Health-Paducah Cancer Center', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'American Oncology Partners, P.A.', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111-5965', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine in Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'SCL Health - Cancer Centers of Montana', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Weill Cornell Medical College - NewYork-Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14467', 'city': 'Rochester', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Rochester Medical Center (URMC) - James P. Wilmot Cancer Center - Pluta Cancer Center (PCC)', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Alliance, Inc.', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Stefanie Spielman Comprehensive Breast Center at Olentangy River Road', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19004', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Rittenhouse Hematology/Oncology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Sanford Health', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '77030-4000', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '63110', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mays Cancer Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23114-3203', 'city': 'Midlothian', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Bon Secours St. Francis Medical Oncology Center', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': 'B1884BBF', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Centro de Oncologia e Investigacion Buenos Aires COIBA', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B2700CPM', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Pergamino Clinic', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1025ABI', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'CENIT Foundation', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1414', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Fleischer Medical Center (Centro Medico Fleischer)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ABP', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Fundacion Respirar', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426AGE', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Centro Oncológico Korben', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ANZ', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Alexander Fleming Institute', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Center for Medical Education and Clinical Research (CEMIC)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5006HBF', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Cordoba Oncology Institute (IONC)', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'La Plata', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Centro Oncologico de Excelencia', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'city': 'La Rioja', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Fundación CORI', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': 'E3100HYB', 'city': 'Paraná', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)', 'geoPoint': {'lat': -31.73271, 'lon': -60.52897}}, {'city': 'Rosario', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': "Rosario's Oncology Institute and Medical Specialities (IOR)", 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '5000', 'city': 'Adelaide', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'GenesisCare - St Andrews', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6009', 'city': 'Nedlands', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Breast Cancer Research Centre', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '4215', 'city': 'Southport', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Icon Cancer Centre Southport', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '2076', 'city': 'Wahroonga', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Sydney Adventist Hospital', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '2145', 'city': 'Westmead', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '1200', 'city': 'Brussels', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6060', 'city': 'Charleroi', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'Grand Hopital De Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '9000', 'city': 'Ghent', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent - Medische Oncologie', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '3000', 'city': 'Leuven', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '66073-005', 'city': 'Belém', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'facility': 'CTO Centro de Tratamento Oncológico', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}, {'zip': '30360-680', 'city': 'Belo Horizonte', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'facility': 'Oncocentro Belo Horizonte', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '60336-232', 'city': 'Fortaleza', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'facility': 'Centro Regional Integrado de Oncologia - 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