This is a Phase 3, open-label, randomly assigned, clinical trial evaluating the how well it works and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Official registry: https://clinicaltrials.gov/study/NCT06757634 · Celcuity Inc · enrollment listed as 1,180
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, or Arm C: Gedatolisib + Palbociclib + Letrozole. The registry lists allocation as randomized. This is a Phase 3, open-label, randomly assigned, clinical trial evaluating the how well it works and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
They plan to enroll about 1,180 people at 239 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole, Arm D: Ribociclib + Letrozole
Primary outcome (registry wording): Progression Free Survival (PFS)
Nadene Zack, MS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 209 sites outside the US on the same record
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
NCT00451022 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.
NCT01174121 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary