Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

VIKTORIA-1 : Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase III study is evaluating how safe and effective targeted therapy (gedatolisib) plus hormone therapy (fulvestrant), with or without additional targeted therapy (palbociclib) is in the treatment of advanced HR+, HER2- breast cancer who have had prior therapy.
 

This trial is treating patients with HR+, HER2- breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

Commercial Sponsor

Celcuity, Inc.

Other Non-Commercial Sponsor

University College London Hospitals

Summary

Eligible participants will be separated into two groups: those lacking PIK3CA Mutations (WT) and those with PIK3CA Mutation (MT). From there, participants will be randomly allocated to a treatment arm. People lacking PIK3CA Mutations (WT) will be randomly assigned to either Experimental Arm A to receive gedatolisib + palbociclib + fulvestrant, Experimental Arm B to receive gedatolisib + fulvestrant, or Active Comparator Arm C to receive fulvestrant alone. People with PIK3CA Mutation (MT) will be randomly assigned to Experimental Arm D to receive gedatolisib + palbociclib + fulvestrant, Active Comparator Arm E to receive alpelisib + fulvestrant, or Experimental Arm F to receive gedatolisib + fulvestrant.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
nadia.ranieri@svha.org.au
03 9231 3167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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