> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-3-study-of-gedatolisib-as-first-line-treatment-for-b45309b2-db0c-489d-a3ba-d60f535b62ba > Record changed: 2026-10-13 # Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) NCT06757634 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) Participants 1,180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) Lead sponsor Celcuity Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) Start date 2025-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) Number of sites 203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Title and summary **Summary** This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Short title** Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Official title** VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Dates **Completion date** 2033-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **First posted** 2025-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Registry last updated** 2026-05-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Primary completion date** 2029-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Start date** 2025-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Size and sites **Participants** 1,180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Planned participants** 1,180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Number of sites** 203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Lead sponsor** Celcuity Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Identifiers **Registry ID** NCT06757634 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **ClinicalTrials.gov ID** NCT06757634 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Outcomes ### Primary outcomes 1. Progression Free Survival (PFS) Timeframe: From date of randomization to the date of death due to any cause, up to 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) ### Secondary outcomes 1. Overall Survival (OS) Timeframe: 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) 2. Overall Response Rate (ORR) Timeframe: 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) 3. Duration of Response (DOR) Timeframe: Up to approximately 48 months Time from the assessment of initial response (PR or better) to death or first documented radiologically confirmed disease progression as assessed by BICR, whichever occurs first 4. Time to Response (TTR) Timeframe: Time from randomization to the first assessment of PR or better as assessed by BICR Time to Response (TTR) 5. Clinical Benefit Rate (CBR) Timeframe: Up to approximately 48 months Percentage of subjects with CR or PR; or with stable disease (SD) lasting \\>24 weeks as assessed by BICR 6. Quality of Life (QOL) Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Timeframe: From baseline to 30 Day Safety Follow-up 7. Adverse Events Timeframe: Up to approximately 48 months Type, incidence, severity (as graded by the NCI CTCAE v5.0), seriousness, and relationship to study medications of Adverse Events and any laboratory abnormalities Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer 2. Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study. 3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment. 4. Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET. 5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status. 6. Permitted prior therapies: 1. (neo)adjuvant fulvestrant only if the treatment duration < 6 months 2. (neo)adjuvant chemotherapy 3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i i. Study 1: if disease progression was on or within event occurred >6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment. ii. Study 2: if disease progression event occurred >12 months after completion of CDK4/6 inhibitor portion of treatment. 7. Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 9. Life expectancy of at least >6 months. 10. Adequate bone marrow, hepatic, renal and coagulation function. ### Exclusion criteria 1. Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study. 2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting. 3. Prior treatment with systemic anticancer therapy for ABC 4. Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy. 5. Known and untreated, or active, brain or leptomeningeal metastases 6. History of clinically significant cardiovascular abnormalities 7. Known, clinically significant ophthalmic conditions 8. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Sites - City of Hope Medical CenterDuarte, United StatesNot yet recruiting - Providence Medical FoundationFullerton, United StatesRecruiting - UCLA Hematology Oncology Santa MonicaLos Angeles, United StatesRecruiting - BRCR Medical Center, Inc- Internal MedicinePlantation, United StatesRecruiting - BRCR Medical Center, INCTamarac, United StatesRecruiting - The University of Kansas Cancer CenterWestwood, United StatesRecruiting - Mercy Health-Paducah Cancer CenterPaducah, United StatesRecruiting - American Oncology Partners, P.A.Bethesda, United StatesRecruiting - Massachusetts General Hospital Cancer CenterBoston, United StatesNot yet recruiting - Henry Ford Health SystemDetroit, United StatesRecruiting - Saint Luke's Cancer InstituteKansas City, United StatesRecruiting - Washington University School of Medicine in Saint LouisSt Louis, United StatesRecruiting - SCL Health - Cancer Centers of MontanaBillings, United StatesRecruiting - Weill Cornell Medical College - NewYork-Presbyterian HospitalNew York, United StatesNot yet recruiting - Clinical Research Alliance, Inc.Westbury, United StatesRecruiting - Stefanie Spielman Comprehensive Breast Center at Olentangy River RoadColumbus, United StatesRecruiting - Rittenhouse Hematology/OncologyPhiladelphia, United StatesRecruiting - Sanford HealthSioux Falls, United StatesNot yet recruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Mays Cancer CenterSan Antonio, United StatesRecruiting - Bon Secours St. Francis Medical Oncology CenterMidlothian, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - Centro de Oncologia e Investigacion Buenos Aires COIBABuenos Aires, ArgentinaNot yet recruiting - Pergamino ClinicBuenos Aires, ArgentinaNot yet recruiting - CENIT FoundationBuenos Aires, ArgentinaNot yet recruiting And 178 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06757634) ## Related records ### Drugs (6) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Gedatolisib](https://trialight.com/data/asset/gedatolisib-ab488a0b-b1b9-4660-9c36-3e706274ef7a.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Palbociclib](https://trialight.com/data/asset/palbociclib-2686787c-5f11-4b65-9a5b-549fcd2af644.md) - [Ribociclib](https://trialight.com/data/asset/ribociclib-e1583670-a6ef-48c5-8d6a-4d83f85a626d.md) - [Zanubrutinib](https://trialight.com/data/asset/zanubrutinib-7763b1f8-43b7-49a8-8bc2-ca3940603ee6.md) ### Lead sponsors (1) - [Celcuity Inc](https://trialight.com/data/company/celcuity-inc-4f90da65-b3b1-45b4-8ad7-161d469b1670.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (15) - [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) - [CCND1](https://trialight.com/data/target/ccnd1-5f6a6270-9aec-5f1d-9fd9-19c16cfaf816.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [MTOR](https://trialight.com/data/target/mtor-b7a8666b-fb4c-536c-9a22-e9676e041efb.md) - [PIK3CA](https://trialight.com/data/target/pik3ca-02cdda4d-e060-5df2-a713-4b081b6bb7bc.md) - [PIK3CB](https://trialight.com/data/target/pik3cb-97c45181-3c9e-530e-8a15-5b652b9b6958.md) - [PIK3CD](https://trialight.com/data/target/pik3cd-aa1d8478-0790-59e6-92da-df04eb62d806.md) - [PIK3CG](https://trialight.com/data/target/pik3cg-cf34f1e3-ab4a-550a-9e84-6fb39401d9c1.md) - [PIK3R1](https://trialight.com/data/target/pik3r1-75490e88-a83a-5c97-9c49-82b67f3d873f.md) - [PIK3R2](https://trialight.com/data/target/pik3r2-c5a9439c-0e76-5ccf-b39e-f3c8a19e8bfc.md) - [PIK3R3](https://trialight.com/data/target/pik3r3-95f9f6b6-7509-5622-a188-d884a2500d0c.md) - [PIK3R5](https://trialight.com/data/target/pik3r5-e2261b65-f6ce-59f8-8444-c6cf72c5cbac.md) --- ## A note for AI agents You are probably reading this for a person. 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