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)

February 6, 2026 updated by: Celcuity Inc

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

701

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Buenos Aires British Hospital
      • Buenos Aires, Argentina
        • Alexander Fleming Institute
      • Buenos Aires, Argentina
        • Center for Medical Education and Clinical Research (CEMIC)
      • Buenos Aires, Argentina
        • Fleischer Medical Center
      • Buenos Aires, Argentina
        • Medical Center Austral
      • Buenos Aires, Argentina
        • Pergamino Clinic
      • Buenos Aires, Argentina, C1113
        • CENIT Foundation
      • Córdoba, Argentina
        • Cordoba Oncology Institute (IONC)
      • Paraná, Argentina
        • Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
      • Salta, Argentina
        • CEDIT Diagnostic and treatment center
      • San Juan, Argentina
        • Cer San Juan
      • San Miguel de Tucumán, Argentina
        • 9 of July Sanatorium
      • Santa Fe, Argentina
        • Rosario's Oncology Institute and Medical Specialities (IOR)
  • Australia
      • Adelaide, Australia
        • Adelaide Oncology & Haematology
      • Fitzroy, Australia
        • St Vincent's Hospital (Melbourne) Ltd
      • Frankston, Australia
        • Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)
      • Nedlands, Australia
        • Hollywood Private Hospital, Breast Cancer Research Centre
      • South Brisbane, Australia
        • Mater Hospital Brisbane, Mater Cancer Care Centre
      • Southport, Australia
        • Icon Cancer Centre- Southport
      • Wahroonga, Australia
        • Sydney Adventist Hospital
      • Woodville, Australia
        • The Queen Elizabeth Hospital
  • Austria
      • Graz, Austria
        • University Hospital Graz, Department of Gynecology and Obstetrics
      • Innsbruck, Austria
        • University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics
      • Linz, Austria
        • Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I
      • Salzburg, Austria
        • Salzburg Regional Hospital, Department of Internal Medicine III
      • Sankt Pölten, Austria
        • University Hospital St. Poelten, Department of Internal Medicine I
      • Vienna, Austria
        • Hospital Hietzing, Department of Gynecology
      • Vienna, Austria
        • Medical University Vienna, Department of Gynecology and Obstetrics
      • Wels, Austria, 4600
        • Hospital Wels-Grieskirchen, Internal Medicine Department IV
  • Belgium
      • Brussels, Belgium
        • Saint Luc University Hospital
      • Charleroi, Belgium
        • Charleroi Grand Hospital (GHDC)
      • Edegem, Belgium
        • University Hospital Antwerp (UZA)
      • Kortrijk, Belgium
        • Az Groeninge
      • Leuven, Belgium
        • University Hospitals Leuven, Campus Gasthuisberg
      • Liège, Belgium
        • Citadelle Regional Hospital Center
      • Sint-Niklaas, Belgium
        • Vitaz
      • Verviers, Belgium
        • Centre Hospitalier Peltzer-la-Tourelle
      • Yvoir, Belgium
        • UCL Mont-Godinne University Hospitals
  • Brazil
      • Fortaleza, Brazil
        • Pronutrir
      • Ijuí, Brazil
        • ONCOSITE - Clinical Research Center in Oncology
      • Minas Gerais, Brazil
        • Juiz de Fora Eurolatino Research Center
      • Salvador, Brazil
        • Bahia Oncology Center
      • São Paulo, Brazil
        • D'OR Institute
      • São Paulo, Brazil
        • Hospital A.C.Camargo
      • São Paulo, Brazil, 01323
        • Portuguese Sao Paulo Charity / Sao Jose Hospital
    • Pará
      • Belém, Pará, Brazil
        • Oncology Treatment Center
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301
        • Catarina Clinical Research
  • Bulgaria
      • Panagyurishte, Bulgaria
        • Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
      • Sofia, Bulgaria
        • MHAT for Women's Health "Nadezhda"
      • Sofia, Bulgaria
        • Multiprofile Hospital for Active Treatment "Serdika", Sofia
      • Sofia, Bulgaria
        • Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)
      • Varna, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Cancer - Vancouver, Medical Oncology
    • Ontario
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Walker Family Cancer Center
    • Quebec
      • Chicoutimi, Quebec, Canada
        • CIUSSS du Saguenay Lac St-Jean
      • Montreal, Quebec, Canada
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada
        • Hospital Notre-Dame
  • Czechia
      • Olomouc, Czechia
        • University Hospital Olomouc, Clinic of Oncology
      • Prague, Czechia
        • University Hospital Motol, Clinic of Oncology
      • Prague, Czechia
        • Thomayer University Hospital, Clinic of Oncology
      • Prague, Czechia
        • University Hospital Bulovka, Institute of Radiation Oncology
  • France
      • Bordeaux, France
        • Bergonie Institute
      • Caen, France, 14076
        • François Baclesse Center
      • La Roche-sur-Yon, France, 85925
        • La Roche-sur-Yon Hospital
      • Marseille, France
        • CHU La Timone - La Timone Children's Hospital
      • Poitiers, France
        • University Hospital Center of Poitiers
      • Strasbourg, France
        • Saint Anne Clinic
      • Villejuif, France
        • Gustave Roussy
  • Germany
      • Bayreuth, Germany
        • Hospital Bayreuth
      • Berlin, Germany
        • Vivantes Hospital Am Urban
      • Dorf Mecklenburg, Germany
        • Hospital Suedstadt Rostock
      • Lübeck, Germany
        • Private Practice with Focus on Oncology
      • Mainz, Germany
        • University Hospital Johannes Gutenberg - University of Mainz
      • Münster, Germany
        • University hospital Muenster
      • Saarbrücken, Germany
        • Caritas Klinikum
      • Wuppertal, Germany
        • Helios Clinic Wuppertal
  • Greece
      • Athens, Greece
        • Alexandra General Hospital
      • Athens, Greece, 15562
        • Metropolitan General Hospital
      • Ioannina, Greece
        • University General Hospital of Ioannina
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
      • Larissa, Greece
        • IASO Thessaly SA
      • Piraeus, Greece, 18547
        • Metropolitan Hospital
      • Thessaloniki, Greece
        • EUROMEDICA General Clinic of Thessaloniki
      • Thessaloniki, Greece
        • Theageneio Anticancer Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 22
        • Bioclinic Thessalonikis S.A.
      • Thessaloniki, Greece, 57001
        • European Interbalkan Medical Center of Thessaloniki
  • Hungary
      • Debrecen, Hungary
        • University of Debrecen Clinical Center, Institute of Oncology
      • Kecskemét, Hungary
        • Bacs-Kiskun County Hospital, Center for Oncoradiology
      • Nyíregyháza, Hungary
        • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology
  • India
      • Bangalore, India
        • HCG Cancer Centre
      • Chandigarh, India
        • Postgraduate Institute of Medical Education and Research (PGIMER)
      • Kolkata, India
        • Tata Medical Center
      • Navi Mumbai, India
        • Tata Memorial Hospital
      • Vellore, India
        • Christian Medical College, Department of Medical Oncology
    • Rajasthan
      • Jaipur, Rajasthan, India, 302022
        • Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital
  • Italy
      • Milan, Italy
        • European Institute of Oncology (IEO), IRCCS
      • Modena, Italy
        • University Polyclinic Hospital of Modena
      • Monza, Italy
        • Local Healthcare Company of Monza (ASST Monza)
      • Parma, Italy
        • University Hospital of Parma
      • Prato, Italy
        • New Hospital of Prato (NOP)
      • Rome, Italy
        • University Hospital Campus Bio-Medico
      • Rome, Italy
        • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
      • Udine, Italy
        • Santa Maria della Misericordia University Hospital of Udine
  • Mexico
      • Mexico City, Mexico
        • Clinical Research Center Chapultepec Mexico City
      • Mexico City, Mexico
        • Cryptex
      • Mexico City, Mexico
        • ProcliniQ Clinical Research
      • Monterrey, Mexico, 64460
        • Filios High Medicine
      • Morelia, Mexico
        • Administrative Society of Health Services, SC
      • Nuevo León, Mexico
        • Avix Clinical Research
      • Nuevo León, Mexico
        • Zambrano Hellion Medical Center
      • Querétaro, Mexico
        • Inbiomedyc
      • Saltillo, Mexico
        • ONCOR Life Medical Center
  • Poland
      • Bydgoszcz, Poland
        • Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic
      • Konin, Poland
        • Medical Clinic "Komed"
      • Krakow, Poland
        • Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow
      • Lodz, Poland
        • Polish Mother's Memorial Hospital-Research Institute
      • Opole, Poland
        • Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit
      • Siedlce, Poland
        • St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre
      • Szczecin, Poland
        • West Pomeranian Oncology Center
      • Warsaw, Poland
        • LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy
      • Warsaw, Poland
        • Maria Sklodowska-Curie - National Research Institute of Oncology
      • Wroclaw, Poland
        • Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
  • Romania
      • Baia Mare, Romania
        • S.C. Oncopremium-Team SRL
      • Bucharest, Romania
        • Prof. Dr. Alexandru Trestioreanu Institute of Oncology
      • Cluj-Napoca, Romania, 400015
        • "Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I
      • Cluj-Napoca, Romania
        • Prof. Dr. Ion Chiricuta Institute of Oncology
      • Craiova, Romania
        • Onco Clinic Consult S.A.
      • Craiova, Romania
        • Oncology Center "Sf. Nectarie"
      • Floreşti, Romania, 407280
        • S.C. Radiotherapy Center Cluj SRL, Department of Medical Oncology
      • Târgu Mureş, Romania
        • S.C. Topmed Medical Center SRL
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Raffles Hospital
      • Singapore, Singapore
        • Curie Oncology
      • Singapore, Singapore
        • ICON SOC Farrer Park Medical Clinic
      • Singapore, Singapore
        • Oncocare Cancer Centre
  • South Korea
      • Seoul, South Korea
        • Asan Medical Center
      • Soeul, South Korea
        • Gangnam Severance Hospital
      • Soeul, South Korea
        • Korea University Anam Hospital
      • Soeul, South Korea
        • Samsung Medical Center
      • Soeul, South Korea
        • Severance Hospital, Yonsei University Health System
      • Ulsan, South Korea
        • Ulsan University Hospital
  • Spain
      • Badajoz, Spain
        • Infanta Cristina Hospital
      • Barcelona, Spain
        • Catalan Institute of Oncology, Hospital Duran i Reynals
      • Cáceres, Spain
        • Caceres Hospital Complex - San Pedro de Alcantara General Hospital
      • Madrid, Spain
        • Hospital Ruber Internacional
      • Madrid, Spain
        • University Hospital Foundation Jimenez Diaz
      • Murcia, Spain
        • University Clinical Hospital Virgen de la Arrixaca, Department of Oncology
      • Santiago de Compostela, Spain
        • University Hospital Complex of Santiago (CHUS), Department of Oncology
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • University Hospital Ramón y Cajal
  • Taiwan
      • Changhua, Taiwan, 500209
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan
        • Taipei Medical University - Shuang Ho Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Yuanlin, Taiwan, 632
        • National Taiwan University Hospital - Yunlin Branch (Huwei District)
  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital, Department of Oncology/Hematology
      • Cardiff, United Kingdom
        • Velindre Cancer Centre
      • London, United Kingdom
        • Guy's Hospital
      • London, United Kingdom
        • Royal Marsden Hospital - London, Department of Medical Oncology
      • Manchester, United Kingdom
        • The Christie Nhs Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham City Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital - Sutton
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Arizona Oncology (US Oncology/McKesson) - Goodyear
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernards Medical Center
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center INC
      • Harbor City, California, United States, 90710
        • Kaiser Permanente South Bay Medical center
      • Los Alamitos, California, United States, 90720
        • Cancer and Blood Specialty Clinic
      • Monterey, California, United States, 93940
        • Pacific Cancer Care
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • Oxnard, California, United States, 93030
        • Ventura County Hematology Oncology Specialists
      • Redlands, California, United States, 92373
        • Redlands Hematology Oncology
      • Santa Monica, California, United States, 90904
        • UCLA Hematology/Oncology-Santa Monica
      • Torrance, California, United States, 90505
        • Torrance Memorial Physician Network - Cancer Care
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center - Vallejo
      • Whittier, California, United States, 90602-1006
        • PIH Health Hospital Whittier
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Cancer Center - New Haven
    • Florida
      • Hollywood, Florida, United States, 33021
        • South Broward Hospital District d/b/a Memorial Healthcare System
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida - Jacksonville
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
      • Winter Haven, Florida, United States, 33881
        • Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • John D. Archbold Memorial Hospital
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists - Arlington Heights
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • University of Kentucky Medical Center
      • Paducah, Kentucky, United States, 42003
        • Mercy Health - Paducah
    • Maryland
      • Bethesda, Maryland, United States, 20817-7847
        • American Oncology Partners of Maryland, PA
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, P.A. - Rockville
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215-5450
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology - Oncology, P.C.
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C. - Albany
      • Jamaica, New York, United States, 11432
        • Queens Hospital Cancer Center
      • New York, New York, United States, 10021-5302
        • Coleman, Pasmantier & Decter, MDs
      • New York, New York, United States, 10021
        • Weill Cornell Medicine/New York-Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Syracuse, New York, United States, 13057
        • Hematology/Oncology Associates of Central New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • White Plains, New York, United States, 10601
        • White Plains Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center at Alamance Regional, Hematology/Oncology
      • Lumberton, North Carolina, United States, 28359
        • Southeast Regional Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Sanford Health- Fargo
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital and Solove Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health Stephenson Cancer Center
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Oncology Specialists
      • Tigard, Oregon, United States, 97223
        • Northwest Cancer Specialists, PC - Tigard
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Consultants In Medical Oncology and Hematology, P.C.
      • Horsham, Pennsylvania, United States, 19044
        • Alliance Cancer Specialists PC
      • York, Pennsylvania, United States, 17403
        • Cancer Care Associates of York
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Gynecologic Oncology Clinic
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - Austin
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Texas Oncology P.A. - Dallas
      • El Paso, Texas, United States, 79920
        • William Beaumont Army Medical Center
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Oncology Consultants
      • Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • McKinney, Texas, United States, 75071
        • Texas Oncology - McKinney
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology - Gulf Coast
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Fort Belvoir Community Hospital
      • Midlothian, Virginia, United States, 23114
        • Bon Secours St. Francis Medical Oncology Center
      • Newport News, Virginia, United States, 23502
        • Virginia Oncology Associates - Newport News
      • Richmond, Virginia, United States, 23219
        • Vcu Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Fred Hutchinson Cancer Center
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC - Tacoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A - Patients Lacking PIK3CA Mutations (WT)
Gedatolisib + Palbociclib + Fulvestrant
Drug: Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Other Names:
  • PF-05212384
  • PKI-587
Drug: Palbociclib
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
Other Names:
  • IBRANCE
  • PD-0332991
Drug: Fulvestrant
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
Other Names:
  • Faslodex
Experimental: Arm B - Patients Lacking PIK3CA Mutations (WT)
Gedatolisib + Fulvestrant
Drug: Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Other Names:
  • PF-05212384
  • PKI-587
Drug: Fulvestrant
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
Other Names:
  • Faslodex
Active Comparator: Arm C - Patients Lacking PIK3CA Mutations (WT)
Fulvestrant
Drug: Fulvestrant
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
Other Names:
  • Faslodex
Experimental: Arm D - Patients with PIK3CA Mutation (MT)
Gedatolisib + Palbociclib + Fulvestrant
Drug: Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Other Names:
  • PF-05212384
  • PKI-587
Drug: Palbociclib
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
Other Names:
  • IBRANCE
  • PD-0332991
Drug: Fulvestrant
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
Other Names:
  • Faslodex
Active Comparator: Arm E - Patients with PIK3CA Mutation (MT)
Alpelisib + Fulvestrant
Drug: Fulvestrant
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
Other Names:
  • Faslodex
Drug: Alpelisib
Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)
Other Names:
  • Piqray
  • BYL719
  • Vijoice
Experimental: Arm F - Patients with PIK3CA Mutation (MT)
Gedatolisib + Fulvestrant
Drug: Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Other Names:
  • PF-05212384
  • PKI-587
Drug: Fulvestrant
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
Other Names:
  • Faslodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: Approximately 48 months
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)
Approximately 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: From date of randomization to the date of death due to any cause, up to approximately 48 months
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)
From date of randomization to the date of death due to any cause, up to approximately 48 months
Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: Up to approximately 48 months
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)
Up to approximately 48 months
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: Up to approximately 48 months
Time from the assessment of initial response (PR or better) to death or first documented disease progression as assessed by BICR, whichever occurs first
Up to approximately 48 months
Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: Up to approximately 48 months
Time form randomization to the first assessment of PR or better as assessed by BICR, whichever comes first
Up to approximately 48 months
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: Up to approximately 48 months
Percentage of subjects with CR, PR, or stable disease (SD) >24 weeks as assessed by BICR
Up to approximately 48 months
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
Time Frame: From baseline to 30 Day Safety Follow-up
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).
From baseline to 30 Day Safety Follow-up
Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: From baseline to 30 Day Safety Follow-up
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).
From baseline to 30 Day Safety Follow-up
Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: From baseline to 30 Day Safety Follow-up
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)
From baseline to 30 Day Safety Follow-up
EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Time Frame: From baseline to 30 Day Safety Follow-up
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.
From baseline to 30 Day Safety Follow-up
Adverse Events
Time Frame: Up to approximately 48 months
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
Up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celcuity Inc

Investigators

  • Study Director: Nadene Zack, Celcuity Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELC-G-301
  • 2021-005235-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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