Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

NCT06757634
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,180
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Lead sponsor
Celcuity Inc
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Start date
2025-07-24
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Number of sites
203
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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.
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Short title
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2033-07-30
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First posted
2025-01-03
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Registry last updated
2026-05-18
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Primary completion date
2029-03-31
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Start date
2025-07-24
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Participants
1,180
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Participant count basis
Estimated
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Planned participants
1,180
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Protocol amendments
2
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Randomisation ratio
1:1
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Number of sites
203
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Celcuity Inc
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06757634
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06757634
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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)

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)

Conditions (2)

Targets (15)