"VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer. "
Status
Active (Recruiting)
Disease
HR-Positive, HER2-Negative Advanced Breast Cancer
Treament Agent
gedatolisib, fulvestrant, Palbociclib, Ribociclib
Study Phase
Phase III
Resources and Links
Physician Name(s)
Dr Mastura Md Yusof
Description
This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor (Investigator's choice of palbociclib or 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 whose disease has progressed during or within 12 months of adjuvant treatment with endocrine therapy (either an AI or tamoxifen), and who have not received prior systemic therapy for ABC. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Following completion of the safety run-in phase to determine the gedatolisib dose with ribociclib, subjects will be assigned to 1 of 2 cohorts based on their PIK3CA status and then randomized to either the investigational treatment arm (gedatolisib with fulvestrant and ribociclib or palbociclib) or standard-of-care control arm (fulvestrant and ribociclib or palbociclib).
Cancer Type
Breast Cancer
I would like to be a part of tomorrow's breakthrough
Clinical trials are part of research studies involving patient volunteers that are conducted to find safe and effective treatments for a variety of health conditions. They are critical to the advancement of medicine and improving patient health. Participating in clinical trials offers patients the opportunity to try new and effective treatments that could potentially improve their condition while taking part in vital research that can benefit many future patients.
In Pantai Hospital Kuala Lumpur, clinical trials are carried out under our Clinical Research team.
If you would like to participate in any of our clinical trials or would like to know, please provide your information below and we will be in touch with you:
8, Jalan Bukit Pantai, 59100 Kuala Lumpur, Malaysia
.webp?sfvrsn=20763f7d_21)
.webp?sfvrsn=f2a2c343_12)
