Taking peoplePhase 3
Tests gedatolisib with endocrine therapy for advanced hormone-positive breast cancer
Tests gedatolisib plus palbociclib and hormone therapy in adults with advanced breast cancer.
Key facts
- Who runs it
- Celcuity Inc
- Where
- Coimbra, Lisbon, and Porto, PortugalSee the 6 sitesAlso in 24 other countries, 231 sites
- Trial code
- Registry title
- Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,180 people, planned
- Started
- 24 Jul 2025
- Expected to end
- 30 Jul 2033
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Arm A: Gedatolisib + Palbociclib + Fulvestrant
- Arm B: Ribociclib + Fulvestrant
- Arm C: Gedatolisib + Palbociclib + Letrozole
- Arm D: Ribociclib + Letrozole
- Record updated
- 9 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic breast cancer that is HR-positive and HER2-negative. They must not have had treatment for the advanced disease yet.
- Age
- 18 years or older
- Sex
- Women and men can join. Pre-menopausal women must be willing to take an LHRH agonist.
- Disease stage
- Metastatic or locally advanced HR+/HER2- breast cancer that can be measured on scans (RECIST v1.1). Bone-only disease that cannot be measured does not count. ECOG performance status 0-2.
- Earlier treatment
- No earlier systemic cancer treatment for the advanced disease. Earlier treatment before or after surgery is allowed: chemotherapy, endocrine therapy, fulvestrant for less than 6 months, or a CDK4/6 inhibitor under set time limits.
- Biomarker or test result
- A tumor tissue sample or liquid biopsy is needed to test PIK3CA mutation status.
Main reasons for not taking part
- Another current cancer, apart from treated non-melanoma skin cancer
- Earlier treatment with a PI3K, Akt or mTOR inhibitor, or a SERD other than fulvestrant
- Type 1 diabetes, or type 2 diabetes needing daily insulin
- Untreated or active brain or leptomeningeal metastases
- Serious heart problems or serious eye conditions
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Portugal
Also in 24 other countries, 231 sites
- Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugalNot yet recruiting
- Hospital Cuf Descobertas S.A.Lisbon, PortugalNot yet recruiting
- Hospital da Luz, S.ALisbon, PortugalNot yet recruiting
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Lisbon, PortugalNot yet recruiting
- Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugalNot yet recruiting
- Unidade Local De Saude De Santo Antonio E.P.E.Porto, PortugalNot yet recruiting
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Arm A: Gedatolisib + Palbociclib + FulvestrantTreatment being tested
Subjects with treatment-naïve endocrine-resistant ABC.
- Arm B: Ribociclib + FulvestrantExisting treatment, for comparison
Subjects with treatment-naïve endocrine-resistant ABC.
- Arm C: Gedatolisib + Palbociclib + LetrozoleTreatment being tested
Subjects with treatment-naïve endocrine-sensitive ABC.
- Arm D: Ribociclib + LetrozoleExisting treatment, for comparison
Subjects with treatment-naïve endocrine-sensitive ABC.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests gedatolisib with endocrine therapy for advanced hormone-positive breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06757634, who can take part
- Record updated
- 9 October 2026