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Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (VIKTORIA-1)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gedatolisib
Palbociclib
Fulvestrant
Alpelisib
Sponsored by
Celcuity, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Advanced or Metastatic, gedatolisib, HR Positive, ER Positive, HER2 Negative, PIK3CA MT, PI3K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer 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 on it for the duration of the study.
  2. Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment
  3. Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
  4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
  5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
  6. Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  8. Life expectancy of at least 3 months
  9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
  10. Adequate bone marrow, hepatic, renal and coagulation function

Exclusion Criteria:

  1. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 years
  2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
  3. Prior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)
  4. More than 2 lines of prior endocrine therapy treatment
  5. Bone only disease that is only blastic with no soft tissue component
  6. Subjects with type 1 diabetes or uncontrolled type 2 diabetes

  7. Known and untreated, or active, brain or leptomeningeal metastases

    a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment

  8. Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term

  9. History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entry

    1. Myocardial infarction within 12 months of study entry
    2. History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months
    3. Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication[s] is allowed prior to screening)

    4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

      • i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia
      • ii. On screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening)
  10. Known hypersensitivity to the study drugs or their components
  11. Pregnant or breast-feeding women

  12. Concurrent participation in another interventional clinical trial

    1. Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Arizona Oncology (US Oncology/McKesson) - GoodyearRecruiting
  • St. Bernards Medical CenterRecruiting
  • CARTI Cancer CenterRecruiting
  • Pacific Cancer Medical Center IncRecruiting
  • Kaiser Permanente South Bay Medical CenterRecruiting
  • Cancer and Blood Specialty ClinicRecruiting
  • Pacific Cancer CareRecruiting
  • University of California, Irvine Medical CenterRecruiting
  • Ventura County Hematology Oncology Specialists
  • Redlands Hematology OncologyRecruiting
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • UCLA Hematology/Oncology-Santa MonicaRecruiting
  • Torrance Memorial Physician Network - Cancer CareRecruiting
  • Kaiser Permanente Medical Center - VallejoRecruiting
  • PIH Health Hospital WhittierRecruiting
  • Yale Cancer Center - New HavenRecruiting
  • South Broward Hospital District d/b/a Memorial Healthcare SystemRecruiting
  • Cancer Specialists of North Florida - JacksonvilleRecruiting
  • H. Lee Moffitt Cancer Center & Research InstituteRecruiting
  • Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.Recruiting
  • John D. Archbold Memorial HospitalRecruiting
  • Illinois Cancer Specialists - Arlington HeightsRecruiting
  • Fort Wayne Medical Oncology and HematologyRecruiting
  • University of Kentucky Medical CenterRecruiting
  • Mercy Health - PaducahRecruiting
  • American Oncology Partners of Maryland, PARecruiting
  • Maryland Oncology Hematology, P.A. - RockvilleRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • Nebraska Hematology - Oncology, P.C.Recruiting
  • Oncology Hematology West PC dba Nebraska Cancer SpecialistsRecruiting
  • University of Nebraska Medical CenterRecruiting
  • New York Oncology Hematology, P.C. - AlbanyRecruiting
  • Montefiore Medical CenterRecruiting
  • Queens Hospital Cancer CenterRecruiting
  • Coleman, Pasmantier & Decter, MDsRecruiting
  • Weill Cornell Medicine/New York-Presbyterian HospitalRecruiting
  • University of Rochester Medical Center
  • Hematology/Oncology Associates of Central New YorkRecruiting
  • White Plains HospitalRecruiting
  • Cone Health Cancer Center at Alamance Regional, Hematology/OncologyRecruiting
  • Southeast Regional Cancer CenterRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • The James Cancer Hospital and Solove Research InstituteRecruiting
  • OU Health Stephenson Cancer CenterRecruiting
  • Oregon Oncology SpecialistsRecruiting
  • Northwest Cancer Specialists, PC - TigardRecruiting
  • Consultants In Medical Oncology and Hematology, P.C.Recruiting
  • Alliance Cancer Specialists PCRecruiting
  • Cancer Care Associates of YorkRecruiting
  • Sanford Gynecologic Oncology ClinicRecruiting
  • Texas Oncology - AustinRecruiting
  • Texas Oncology P.A. - DallasRecruiting
  • Texas Oncology - Baylor Charles A. Sammons Cancer CenterRecruiting
  • William Beaumont Army Medical CenterRecruiting
  • Oncology ConsultantsRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • Brooke Army Medical CenterRecruiting
  • Texas Oncology - McKinneyRecruiting
  • Texas Oncology - Gulf CoastRecruiting
  • Texas Oncology - TylerRecruiting
  • Fort Belvoir Community HospitalRecruiting
  • Bon Secours St. Francis Medical Oncology CenterRecruiting
  • Virginia Oncology Associates - Newport NewsRecruiting
  • VCU Massey Cancer CenterRecruiting
  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - RoanokeRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • Northwest Medical Specialties, PLLC - TacomaRecruiting
  • Alexander Fleming InstituteRecruiting
  • Buenos Aires British HospitalRecruiting
  • CENIT FoundationRecruiting
  • Center for Medical Education and Clinical Research (CEMIC)Recruiting
  • Fleischer Medical CenterRecruiting
  • Medical Center AustralRecruiting
  • Pergamino Clinic
  • Cordoba Oncology Institute (IONC)Recruiting
  • Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)Recruiting
  • CEDIT Diagnostic and treatment centerRecruiting
  • CER San JuanRecruiting
  • Rosario's Oncology Institute and Medical Specialities (IOR)Recruiting
  • 9 of July SanatoriumRecruiting
  • Adelaide Oncology & HaematologyRecruiting
  • St Vincent's Hospital (Melbourne) LtdRecruiting
  • Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)Recruiting
  • Hollywood Private Hospital, Breast Cancer Research CentreRecruiting
  • Mater Hospital Brisbane, Mater Cancer Care CentreRecruiting
  • Icon Cancer Centre- SouthportRecruiting
  • Sydney Adventist HospitalRecruiting
  • The Queen Elizabeth HospitalRecruiting
  • University Hospital Graz, Department of Gynecology and ObstetricsRecruiting
  • University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and ObstetricsRecruiting
  • Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine IRecruiting
  • Salzburg Regional Hospital, Department of Internal Medicine IIIRecruiting
  • University Hospital St. Poelten, Department of Internal Medicine IRecruiting
  • Hospital Hietzing, Department of GynecologyRecruiting
  • Medical University Vienna, Department of Gynecology and ObstetricsRecruiting
  • Saint Luc University HospitalRecruiting
  • Charleroi Grand Hospital (GHDC)Recruiting
  • University Hospital Antwerp (UZA)Recruiting
  • AZ GroeningeRecruiting
  • University Hospitals Leuven, Campus GasthuisbergRecruiting
  • Citadelle Regional Hospital CenterRecruiting
  • VITAZRecruiting
  • Centre Hospitalier Peltzer-la-TourelleRecruiting
  • UCL Mont-Godinne University HospitalsRecruiting
  • Oncology Treatment CenterRecruiting
  • PronutrirRecruiting
  • ONCOSITE - Clinical Research Center in OncologyRecruiting
  • Juiz de Fora Eurolatino Research CenterRecruiting
  • Bahia Oncology CenterRecruiting
  • D'OR InstituteRecruiting
  • Hospital A.C.CamargoRecruiting
  • Multiprofile Hospital for Active Treatment - Uni Hospital, PanagyurishteRecruiting
  • MHAT for Women's Health "Nadezhda"Recruiting
  • Multiprofile Hospital for Active Treatment "Serdika", SofiaRecruiting
  • Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)Recruiting
  • University Multiprofile Hospital for Active Treatment "Sveta Marina"Recruiting
  • BC Cancer - Vancouver, Medical Oncology
  • CIUSSS du Saguenay Lac St-JeanRecruiting
  • Hospital Notre-Dame
  • Maisonneuve-Rosemont HospitalRecruiting
  • University Hospital Olomouc, Clinic of OncologyRecruiting
  • Thomayer University Hospital, Clinic of OncologyRecruiting
  • University Hospital Bulovka, Institute of Radiation OncologyRecruiting
  • University Hospital Motol, Clinic of OncologyRecruiting
  • Bergonie InstituteRecruiting
  • Francois Baclesse CenterRecruiting
  • La Roche-sur-Yon HospitalRecruiting
  • CHU La Timone - La Timone Children's HospitalRecruiting
  • University Hospital Center of PoitiersRecruiting
  • Saint Anne ClinicRecruiting
  • Gustave RoussyRecruiting
  • Hospital BayreuthRecruiting
  • Vivantes Hospital Am UrbanRecruiting
  • Private Practice with Focus on OncologyRecruiting
  • University Hospital Johannes Gutenberg - University of MainzRecruiting
  • Hospital Suedstadt RostockRecruiting
  • University Hospital MuensterRecruiting
  • Caritas KlinikumRecruiting
  • Helios Clinic WuppertalRecruiting
  • Alexandra General HospitalRecruiting
  • University General Hospital of IoanninaRecruiting
  • IASO Thessaly SARecruiting
  • EUROMEDICA General Clinic of ThessalonikiRecruiting
  • Theageneio Anticancer Hospital of ThessalonikiRecruiting
  • University of Debrecen Clinical Center, Institute of OncologyRecruiting
  • Bacs-Kiskun County Hospital, Center for OncoradiologyRecruiting
  • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of OncologyRecruiting
  • HCG Cancer Centre
  • Postgraduate Institute of Medical Education and Research (PGIMER)
  • Tata Medical Center
  • Tata Memorial Hospital
  • Christian Medical College, Department of Medical Oncology
  • European Institute of Oncology (IEO), IRCCSRecruiting
  • University Polyclinic Hospital of ModenaRecruiting
  • Local Healthcare Company of Monza (ASST Monza)Recruiting
  • University Hospital of ParmaRecruiting
  • New Hospital of Prato (NOP)Recruiting
  • University Hospital Campus Bio-MedicoRecruiting
  • University Polyclinic Foundation "Agostino Gemelli" - IRCCSRecruiting
  • Santa Maria della Misericordia University Hospital of UdineRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Ulsan University HospitalRecruiting
  • Clinical Research Center Chapultepec Mexico CityRecruiting
  • CRYPTEXRecruiting
  • ProcliniQ Clinical ResearchRecruiting
  • Filios High MedicineRecruiting
  • Administrative Society of Health Services, SCRecruiting
  • Avix Clinical ResearchRecruiting
  • Zambrano Hellion Medical CenterRecruiting
  • InbiomedycRecruiting
  • ONCOR Life Medical CenterRecruiting
  • Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient ClinicRecruiting
  • Medical Clinic "Komed"Recruiting
  • Maria Sklodowska-Curie Institute of Oncology, Branch in KrakowRecruiting
  • Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization UnitRecruiting
  • St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology CentreRecruiting
  • West Pomeranian Oncology CenterRecruiting
  • LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/ChemotherapyRecruiting
  • Maria Sklodowska-Curie - National Research Institute of OncologyRecruiting
  • Provincial Specialist Hospital in Wroclaw, Department of ChemotherapyRecruiting
  • Polish Mother's Memorial Hospital-Research InstituteRecruiting
  • S.C. Oncopremium-Team SRLRecruiting
  • Prof. Dr. Alexandru Trestioreanu Institute of OncologyRecruiting
  • Prof. Dr. Ion Chiricuta Institute of OncologyRecruiting
  • Onco Clinic Consult S.A.Recruiting
  • Oncology Center "Sf. Nectarie"Recruiting
  • S.C. Topmed Medical Center SRLRecruiting
  • Curie OncologyRecruiting
  • ICON SOC Farrer Park Medical ClinicRecruiting
  • OncoCare Cancer CentreRecruiting
  • Raffles HospitalRecruiting
  • Tan Tock Seng HospitalRecruiting
  • Infanta Cristina HospitalRecruiting
  • Catalan Institute of Oncology, Hospital Duran i ReynalsRecruiting
  • Caceres Hospital Complex - San Pedro de Alcantara General HospitalRecruiting
  • Hospital Ruber InternacionalRecruiting
  • University Hospital Foundation Jimenez DiazRecruiting
  • University Clinical Hospital Virgen de la Arrixaca, Department of OncologyRecruiting
  • University Hospital Complex of Santiago (CHUS), Department of OncologyRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Taipei Medical University - Shuang Ho Hospital
  • China Medical University Hospital
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General Hospital
  • Royal United Hospital, Department of Oncology/Hematology
  • Velindre Cancer Centre
  • Guy's Hospital
  • Royal Marsden Hospital - London, Department of Medical Oncology
  • The Christie NHS Foundation Trust
  • Nottingham City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Arm A - Patients Lacking PIK3CA Mutations (WT)

Arm B - Patients Lacking PIK3CA Mutations (WT)

Arm C - Patients Lacking PIK3CA Mutations (WT)

Arm D - Patients with PIK3CA Mutation (MT)

Arm E - Patients with PIK3CA Mutation (MT)

Arm F - Patients with PIK3CA Mutation (MT)

Arm Description

Gedatolisib + Palbociclib + Fulvestrant

Gedatolisib + Fulvestrant

Fulvestrant

Gedatolisib + Palbociclib + Fulvestrant

Alpelisib + Fulvestrant

Gedatolisib + Fulvestrant

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
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)

Secondary Outcome Measures

Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
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)
Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
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)
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time from the assessment of initial response (PR or better) to death or first documented disease progression as assessed by BICR, whichever occurs first
Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time form randomization to the first assessment of PR or better as assessed by BICR, whichever comes first
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Percentage of subjects with CR, PR, or stable disease (SD) >24 weeks as assessed by BICR
Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
The FACT-B TOI is an abbreviated (24-item) version of the full FACT-B which focuses only on the patient's Physical Well-being (PWB), Functional Well-being (FWB), and Breast Cancer Subscale (BCS) components using a 5-level scale, (Not at all, A little bit, Some-what, Quite a bit, Very much).
Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
NCCN-FACT is derived from the FACT-B and only 4 additional items will be administered to enable optional scoring of the NFBSI subscales and total score using a 5-level scale (Not at all, A little bit, Some-what, Quite a bit, Very much).
Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 - Physical Function 8c using a 5-level scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do)
EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
EuroQol 5 Dimension 5 Level (EQ-5D-5L) - This is a 5 question, self-administered visual analog scale (VAS) where patients use 0 (worst health) to 100 (best health) to indicate how they view their health.
Adverse Events
Safety and tolerability will be evaluated by review of type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities

Full Information

First Posted
August 12, 2022
Last Updated
July 30, 2023
Sponsor
Celcuity, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05501886
Brief Title
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
Acronym
VIKTORIA-1
Official Title
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celcuity, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
Detailed Description
This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Advanced or Metastatic, gedatolisib, HR Positive, ER Positive, HER2 Negative, PIK3CA MT, PI3K

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
701 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Patients Lacking PIK3CA Mutations (WT)
Arm Type
Experimental
Arm Description
Gedatolisib + Palbociclib + Fulvestrant
Arm Title
Arm B - Patients Lacking PIK3CA Mutations (WT)
Arm Type
Experimental
Arm Description
Gedatolisib + Fulvestrant
Arm Title
Arm C - Patients Lacking PIK3CA Mutations (WT)
Arm Type
Active Comparator
Arm Description
Fulvestrant
Arm Title
Arm D - Patients with PIK3CA Mutation (MT)
Arm Type
Experimental
Arm Description
Gedatolisib + Palbociclib + Fulvestrant
Arm Title
Arm E - Patients with PIK3CA Mutation (MT)
Arm Type
Active Comparator
Arm Description
Alpelisib + Fulvestrant
Arm Title
Arm F - Patients with PIK3CA Mutation (MT)
Arm Type
Experimental
Arm Description
Gedatolisib + Fulvestrant
Intervention Type
Drug
Intervention Name(s)
Gedatolisib
Other Intervention Name(s)
PF-05212384, PKI-587
Intervention Description
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Other Intervention Name(s)
IBRANCE, PD-0332991
Intervention Description
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1
Intervention Type
Drug
Intervention Name(s)
Alpelisib
Other Intervention Name(s)
Piqray, Vijoice, BYL719
Intervention Description
Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
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)
Time Frame
Approximately 48 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
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)
Time Frame
From date of randomization to the date of death due to any cause, up to approximately 48 months
Title
Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
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)
Time Frame
Up to approximately 48 months
Title
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
Time from the assessment of initial response (PR or better) to death or first documented disease progression as assessed by BICR, whichever occurs first
Time Frame
Up to approximately 48 months
Title
Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
Time form randomization to the first assessment of PR or better as assessed by BICR, whichever comes first
Time Frame
Up to approximately 48 months
Title
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
Percentage of subjects with CR, PR, or stable disease (SD) >24 weeks as assessed by BICR
Time Frame
Up to approximately 48 months
Title
Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
The FACT-B TOI is an abbreviated (24-item) version of the full FACT-B which focuses only on the patient's Physical Well-being (PWB), Functional Well-being (FWB), and Breast Cancer Subscale (BCS) components using a 5-level scale, (Not at all, A little bit, Some-what, Quite a bit, Very much).
Time Frame
From baseline to 30 Day Safety Follow-up
Title
Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
NCCN-FACT is derived from the FACT-B and only 4 additional items will be administered to enable optional scoring of the NFBSI subscales and total score using a 5-level scale (Not at all, A little bit, Some-what, Quite a bit, Very much).
Time Frame
From baseline to 30 Day Safety Follow-up
Title
Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 - Physical Function 8c using a 5-level scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do)
Time Frame
From baseline to 30 Day Safety Follow-up
Title
EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Description
EuroQol 5 Dimension 5 Level (EQ-5D-5L) - This is a 5 question, self-administered visual analog scale (VAS) where patients use 0 (worst health) to 100 (best health) to indicate how they view their health.
Time Frame
From baseline to 30 Day Safety Follow-up
Title
Adverse Events
Description
Safety and tolerability will be evaluated by review of type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities
Time Frame
Up to approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer 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 on it for the duration of the study. Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Life expectancy of at least 3 months Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI) Adequate bone marrow, hepatic, renal and coagulation function Exclusion Criteria: History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 years Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor Prior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted) More than 2 lines of prior endocrine therapy treatment Bone only disease that is only blastic with no soft tissue component Subjects with type 1 diabetes or uncontrolled type 2 diabetes Known and untreated, or active, brain or leptomeningeal metastases a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entry Myocardial infarction within 12 months of study entry History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication[s] is allowed prior to screening) Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia ii. On screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening) Known hypersensitivity to the study drugs or their components Pregnant or breast-feeding women Concurrent participation in another interventional clinical trial Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadene Zack, MS
Phone
844-310-3900
Email
VIKTORIA-1_TRIAL@CELCUITY.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadene Zack
Organizational Affiliation
Celcuity, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Oncology (US Oncology/McKesson) - Goodyear
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Name
CARTI Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Cancer Medical Center Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente South Bay Medical Center
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer and Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Cancer Care
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Redlands Hematology Oncology
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UCLA Hematology/Oncology-Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90904
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance Memorial Physician Network - Cancer Care
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Recruiting
Facility Name
PIH Health Hospital Whittier
City
Whittier
State/Province
California
ZIP/Postal Code
90602-1006
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center - New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Individual Site Status
Recruiting
Facility Name
South Broward Hospital District d/b/a Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Specialists of North Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Individual Site Status
Recruiting
Facility Name
John D. Archbold Memorial Hospital
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Cancer Specialists - Arlington Heights
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Health - Paducah
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Recruiting
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817-7847
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology, P.A. - Rockville
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5450
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Hematology - Oncology, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology West PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Oncology Hematology, P.C. - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Queens Hospital Cancer Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Recruiting
Facility Name
Coleman, Pasmantier & Decter, MDs
City
New York
State/Province
New York
ZIP/Postal Code
10021-5302
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medicine/New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hematology/Oncology Associates of Central New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Recruiting
Facility Name
Cone Health Cancer Center at Alamance Regional, Hematology/Oncology
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeast Regional Cancer Center
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28359
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
Country
United States
Individual Site Status
Recruiting
Facility Name
The James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Oncology Specialists
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Cancer Specialists, PC - Tigard
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
Consultants In Medical Oncology and Hematology, P.C.
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Cancer Specialists PC
City
Horsham
State/Province
Pennsylvania
ZIP/Postal Code
19044
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Associates of York
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Individual Site Status
Recruiting
Facility Name
Sanford Gynecologic Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology P.A. - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Brooke Army Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Gulf Coast
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Individual Site Status
Recruiting
Facility Name
Bon Secours St. Francis Medical Oncology Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Oncology Associates - Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
VCU Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Medical Specialties, PLLC - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Alexander Fleming Institute
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Buenos Aires British Hospital
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CENIT Foundation
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Center for Medical Education and Clinical Research (CEMIC)
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fleischer Medical Center
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Medical Center Austral
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Pergamino Clinic
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Cordoba Oncology Institute (IONC)
City
Córdoba
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
City
Paraná
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CEDIT Diagnostic and treatment center
City
Salta
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CER San Juan
City
San Juan
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Rosario's Oncology Institute and Medical Specialities (IOR)
City
Santa Fe
Country
Argentina
Individual Site Status
Recruiting
Facility Name
9 of July Sanatorium
City
Tucumán
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Adelaide Oncology & Haematology
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital (Melbourne) Ltd
City
Fitzroy
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)
City
Frankston
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hollywood Private Hospital, Breast Cancer Research Centre
City
Nedlands
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mater Hospital Brisbane, Mater Cancer Care Centre
City
South Brisbane
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Centre- Southport
City
Southport
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Adventist Hospital
City
Wahroonga
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Queen Elizabeth Hospital
City
Woodville
Country
Australia
Individual Site Status
Recruiting
Facility Name
University Hospital Graz, Department of Gynecology and Obstetrics
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Name
University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Name
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Name
Salzburg Regional Hospital, Department of Internal Medicine III
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Name
University Hospital St. Poelten, Department of Internal Medicine I
City
St. Poelten
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hospital Hietzing, Department of Gynecology
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medical University Vienna, Department of Gynecology and Obstetrics
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Name
Saint Luc University Hospital
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Charleroi Grand Hospital (GHDC)
City
Charleroi
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Antwerp (UZA)
City
Edegem
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospitals Leuven, Campus Gasthuisberg
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Citadelle Regional Hospital Center
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Name
VITAZ
City
Sint-Niklaas
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Peltzer-la-Tourelle
City
Verviers
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UCL Mont-Godinne University Hospitals
City
Yvoir
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Oncology Treatment Center
City
Belém
State/Province
Pará
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Pronutrir
City
Fortaleza
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ONCOSITE - Clinical Research Center in Oncology
City
Ijuí
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Juiz de Fora Eurolatino Research Center
City
Minas Gerais
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Bahia Oncology Center
City
Salvador de Bahia
Country
Brazil
Individual Site Status
Recruiting
Facility Name
D'OR Institute
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital A.C.Camargo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
City
Panagyurishte
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT for Women's Health "Nadezhda"
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment "Serdika", Sofia
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment "Sveta Marina"
City
Varna
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
BC Cancer - Vancouver, Medical Oncology
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
CIUSSS du Saguenay Lac St-Jean
City
Chicoutimi
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hospital Notre-Dame
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Maisonneuve-Rosemont Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Hospital Olomouc, Clinic of Oncology
City
Olomouc
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Thomayer University Hospital, Clinic of Oncology
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Bulovka, Institute of Radiation Oncology
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Motol, Clinic of Oncology
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Bergonie Institute
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Name
Francois Baclesse Center
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Name
La Roche-sur-Yon Hospital
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Name
CHU La Timone - La Timone Children's Hospital
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Name
University Hospital Center of Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Name
Saint Anne Clinic
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Bayreuth
City
Bayreuth
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vivantes Hospital Am Urban
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Private Practice with Focus on Oncology
City
Luebeck
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Johannes Gutenberg - University of Mainz
City
Mainz
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hospital Suedstadt Rostock
City
Mecklenburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Muenster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Name
Caritas Klinikum
City
Saarbrücken
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Clinic Wuppertal
City
Wuppertal
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Ioannina
City
Ioánnina
Country
Greece
Individual Site Status
Recruiting
Facility Name
IASO Thessaly SA
City
Larissa
Country
Greece
Individual Site Status
Recruiting
Facility Name
EUROMEDICA General Clinic of Thessaloniki
City
Thessaloníki
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theageneio Anticancer Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Individual Site Status
Recruiting
Facility Name
University of Debrecen Clinical Center, Institute of Oncology
City
Debrecen
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bacs-Kiskun County Hospital, Center for Oncoradiology
City
Kecskemét
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology
City
Nyíregyháza
Country
Hungary
Individual Site Status
Recruiting
Facility Name
HCG Cancer Centre
City
Bangalore
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Postgraduate Institute of Medical Education and Research (PGIMER)
City
Chandigarh
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Tata Medical Center
City
Kolkata
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Tata Memorial Hospital
City
Navi Mumbai
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Christian Medical College, Department of Medical Oncology
City
Vellore
Country
India
Individual Site Status
Not yet recruiting
Facility Name
European Institute of Oncology (IEO), IRCCS
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
University Polyclinic Hospital of Modena
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Name
Local Healthcare Company of Monza (ASST Monza)
City
Monza
Country
Italy
Individual Site Status
Recruiting
Facility Name
University Hospital of Parma
City
Parma
Country
Italy
Individual Site Status
Recruiting
Facility Name
New Hospital of Prato (NOP)
City
Prato
Country
Italy
Individual Site Status
Recruiting
Facility Name
University Hospital Campus Bio-Medico
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Name
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Name
Santa Maria della Misericordia University Hospital of Udine
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Chapultepec Mexico City
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Name
CRYPTEX
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Name
ProcliniQ Clinical Research
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Filios High Medicine
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Administrative Society of Health Services, SC
City
Morelia
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Avix Clinical Research
City
Nuevo León
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Zambrano Hellion Medical Center
City
Nuevo León
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Inbiomedyc
City
Querétaro
Country
Mexico
Individual Site Status
Recruiting
Facility Name
ONCOR Life Medical Center
City
Saltillo
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medical Clinic "Komed"
City
Konin
Country
Poland
Individual Site Status
Recruiting
Facility Name
Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Name
Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit
City
Opole
Country
Poland
Individual Site Status
Recruiting
Facility Name
St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre
City
Siedlce
Country
Poland
Individual Site Status
Recruiting
Facility Name
West Pomeranian Oncology Center
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Name
LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Name
Maria Sklodowska-Curie - National Research Institute of Oncology
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Name
Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
City
Wroclaw
Country
Poland
Individual Site Status
Recruiting
Facility Name
Polish Mother's Memorial Hospital-Research Institute
City
Łódź
Country
Poland
Individual Site Status
Recruiting
Facility Name
S.C. Oncopremium-Team SRL
City
Baia Mare
Country
Romania
Individual Site Status
Recruiting
Facility Name
Prof. Dr. Alexandru Trestioreanu Institute of Oncology
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Name
Prof. Dr. Ion Chiricuta Institute of Oncology
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Name
Onco Clinic Consult S.A.
City
Craiova
Country
Romania
Individual Site Status
Recruiting
Facility Name
Oncology Center "Sf. Nectarie"
City
Craiova
Country
Romania
Individual Site Status
Recruiting
Facility Name
S.C. Topmed Medical Center SRL
City
Târgu-Mureş
Country
Romania
Individual Site Status
Recruiting
Facility Name
Curie Oncology
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
ICON SOC Farrer Park Medical Clinic
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
OncoCare Cancer Centre
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Raffles Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Infanta Cristina Hospital
City
Badajoz
Country
Spain
Individual Site Status
Recruiting
Facility Name
Catalan Institute of Oncology, Hospital Duran i Reynals
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
City
Cáceres
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ruber Internacional
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Foundation Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Clinical Hospital Virgen de la Arrixaca, Department of Oncology
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Complex of Santiago (CHUS), Department of Oncology
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University - Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Royal United Hospital, Department of Oncology/Hematology
City
Bath
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Marsden Hospital - London, Department of Medical Oncology
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Nottingham City Hospital
City
Nottingham
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

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