Tests gedatolisib with endocrine therapy for advanced hormone-positive breast cancer
Tests gedatolisib plus palbociclib and hormone therapy in adults with advanced breast cancer.
Plain-language title generated from the registry record
Registry title: Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Key facts
- Where
- Fano, Genoa, Meldola, Milan, Modena, Naples, Parma, Pavia, Prato, Ravenna, Rome, Rozzano, Terni, and Verona, ItalySee the 15 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you already had any medicine for your cancer after it spread or became advanced?
- Have you had chemotherapy for cancer that has spread or is advanced?
Source: NCT06757634, who can take part
Where in Italy
- Azienda Sanitaria Territoriale Di Pesaro E UrbinoFano, ItalyNot yet recruiting
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNot yet recruiting
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyNot yet recruiting
- Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyNot yet recruiting
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria ParmaParma, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
- Azienda USL Toscana CentroPrato, ItalyNot yet recruiting
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
- Azienda Ospedaliera S Maria Di TerniTerni, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celcuity Inc
- Trial code
- NCT06757634EU 2024-518933-28-01
- Record updated
- 9 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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:; (neo)adjuvant fulvestrant only if the treatment duration < 6 months; (neo)adjuvant chemotherapy; (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i; Study 1: if disease progression was on or within event occurred >6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment; 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: 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; Prior treatment with systemic anticancer therapy for ABC; 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; Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy; History of clinically significant cardiovascular abnormalities; Known, clinically significant ophthalmic conditions; History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis; Known and untreated, or active, brain or leptomeningeal metastases.