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
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
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.
This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus endocrine therapy and palbociclib versus endocrine therapy and ribociclib for the treatment of patients with advanced (inoperable) or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer. Following completion of the screening procedures to determine eligibility, patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control.
Study 1 is expected to enroll approximately 440 subjects with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of the investigational arm (gedatolisib combined with palbociclib and fulvestrant - Arm A) compared to the control arm (ribociclib combined with fulvestrant - Arm B).
Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of the investigational arm (gedatolisib combined with palbociclib and letrozole - Arm C) compared to the control arm (ribociclib combined with letrozole - Arm D).
Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib and ribociclib are CDK4/6 inhibitors. Fulvestrant is a selective estrogen receptor degrader (SERD). Letrozole is an aromatase inhibitor (AI).
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- 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 for the duration of the study.
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.
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.
Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
Permitted prior therapies:
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.
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Life expectancy of at least >6 months.
Adequate bone marrow, hepatic, renal and coagulation function.
Exclusion Criteria:
viktoria-2_trial@celcuity.com844-310-3900
Boston, Massachusetts 02114, United States
St Louis, Missouri 63110, United States
New York, New York 10065, United States
Columbus, Ohio 43210, United States
Midlothian, Virginia 23114-3203, United States
Buenos Aires, B1884BBF, Argentina
Paraná, E3100HYB, Argentina
Ribeirão Preto, 14051-140, Brazil
Panagyurishte, 4500, Bulgaria
Sofia, 1632, Bulgaria
Hořovice, 268 31, Czechia
Prague, 100 34, Czechia
Amiens, 80054, France
Dijon, 21079, France
Poitiers, 86000, France
Saint-Herblain, 44805, France
Debrecen, 4032, Hungary
Gyula, 5700, Hungary
Genova, 16132, Italy
Modena, 41124, Italy
Bydgoszcz, 85796, Poland
Opole, 45060, Poland
Szczecin, 71730, Poland
Warsaw, 01748, Poland
Warsaw, 02781, Poland
Lisbon, 1099-023, Portugal
Lisbon, 1649-035, Portugal
Porto, 4099-001, Portugal
Cluj-Napoca, 022328, Romania
Seoul, 6591, South Korea
Cáceres, 10002, Spain
Santiago de Compostela, 15706, Spain
Changhua, 500209, Taiwan
Douliu, 640203, Taiwan
Kaohsiung City, 807377, Taiwan
Taipei, 112201, Taiwan
Taipei, 116079, Taiwan
Ankara, 06200, Turkey (Türkiye)
Diyarbakır, 21280, Turkey (Türkiye)
Istanbul, 34153, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Konya, 42080, Turkey (Türkiye)