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VIKTORIA-1 Trial Summary
This trial tests a combination of drugs to treat advanced breast cancer after other treatments have stopped working.
- Breast Cancer
VIKTORIA-1 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
VIKTORIA-1 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
VIKTORIA-1 Trial Design
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Who is running the clinical trial?
- You have HER2 IHC negative as per ASCO-CAP 2018 guideline.Female subjects who are not surgically sterile must use a medically-effective contraceptive method from screening until 1 year after the last dose of study treatment.You are expected to live for at least three more months.
- Group 1: Arm F - Patients with PIK3CA Mutation (MT)
- Group 2: Arm A - Patients Lacking PIK3CA Mutations (WT)
- Group 3: Arm B - Patients Lacking PIK3CA Mutations (WT)
- Group 4: Arm C - Patients Lacking PIK3CA Mutations (WT)
- Group 5: Arm D - Patients with PIK3CA Mutation (MT)
- Group 6: Arm E - Patients with PIK3CA Mutation (MT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people can join this trial at most?
"In order to move forward with this clinical trial, 701 patients that meet the specified inclusion criteria must enroll. These potential participants can be based out of CARTI Cancer Center in Little Rock, Arkansas or Oncology, ArkansRTI Cancer Center in Little Rock, Arkansas or Oncology Consultants in Houston, Texas."
What are the FDA regulations surrounding patients who lack PIK3CA mutations?
"Arm A - Patients Lacking PIK3CA Mutations (WT) is backed by prior clinical data and Phase 3 trials, making it a safe option with a score of 3."
Can people sign up for this clinical trial at the moment?
"Yes, as per the information available on clinicaltrials.gov this trial is still ongoing and looking for participants. The listing was first created on September 30th, 2020 with the most recent update occurring on November 9th, 2020."
In how many diverse places is this experiment being conducted?
"As of right now, the clinical trial is being conducted at 76 different sites. These locations include Little Rock, Houston and Jonesboro. To cut down on travel time and effort, patients are encouraged to enroll at the location nearest them."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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